CLASS III Drug recall · Reported 30 Apr 2014 · FDA Enforcement Report

Day Time Cold & Flu, Multi-Symptom, Non-Drowsy recalled

P&L Developments is recalling Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, distributed nationwide in the US. The recall was initiated on 14 Apr 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot # (expiry): Aaron Health A-D) 72493 (5/14), 75241 (7/14), 77879 (8/14), 78795 (9/14), 81058 (11/14), 81118 (10/14), 81578 (10/14), 82076 (10/14), 82023 (11/14), 140756 (1/15), 141655 (11/14), 141882 (3/15), 142086 (2/15), 144257 (1/15), 147361 (3/15), 148288 (6/15), 149143 (7/15), 149512 (7/15), 149741 (8/15), 150307 (9/15), 152290 (3/15), 152666 (11/15), 152752 (8/15), 154931 (10/15), 155111 (1/16). BestChoice E-F) 76825 (7/14), 78792 (7/14), 78798 (9/14), 79357 (6/14), 79732 (9/14), 79733 (9/14), 81066 (11/14), 81695 (10/14), 83452 (12/14), 83682 (1/15), 83843 (1/15), 140395 (1/15), 142314 (3/15), 147440 (1/15), 148095 (6/15), 149404 (8/15), 149445 (8/15), 152521 (8/15), 152521 (8/15), 152866 (8/15), 153069 (8/15), 153900 (12/15), 154463 (12/15), 154919 (12/14), 154957 (1/14). CareOne G-H) 73250 (5/14), 77891 (8/14), 78801 (9/14), 81580 (10/14), 7325001 (5/14), 7397801 (6/14), 7788001 (8/14), 8158001 (10/14), 8321501 (1/15), 14048301 (1/15), 14126901 (2/15). Drug Mart I) 77886 (8/14), 83479 (1/15), 141268 (2/15), 143648 (3/15), 144828 (3/15), 148472 (6/15), 148483 (6/15), 151620 (10/15), 152667 (11/15). Duanereade J-K) 73377 (5/14), 73977 (5/14), 74888 (5/14), 76136 (7/14), 77068 (7/14), 77875 (7/14), 80308 (7/14), 81067 (11/14), 81069 (10/14). Equate L-M) 73736 (6/14), 74386 (6/14), 75111 (7/14), 75824 (7/14), 76826 (8/14), 78210 (9/14), 78417 (9/14), 78457 (9/14), 78858 (9/14), 78859 (9/14), 78860 (9/14), 79182 (10/14), 79564 (10/14), 80310 (10/14), 80311 (10/14), 80312 (10/14), 81071 (10/14), 81184 (11/14), 81331 (11/14), 81931 (12/14), 82010 (12/14), 82533 (12/14), 82913 (12/14), 83797 (12/14), 83798 (12/14), 83799 (12/14), 83943 (1/15), 84098 (1/15), 140937 (2/15), 141126 (2/15), 141127 (2/15), 141204 (2/15), 141831 (2/15), 143619 (2/15), 145776 (2/15), 146377 (2/15), 146766 (2/15), 147479 (2/14), 148254 (2/15), 148733 (8/15), 148876 (2/15), 148877 (2/15), 149282 (8/15), 149497 (8/15), 150586 (8/15), 150922 (8/15), 150923 (9/15), 151132 (9/15), 151261 (10/15), 152254 (10/15), 152447 (11/15), 152758 (11/15), 152759 (11/15), 153095 (11/15), 153096 (11/15), 153714 (11/15), 154488 (122/15), 154980 (1/16), 155574 (1/16). Exchange Select N) 71901 (5/14), 72662 (5/14), 73737 (6/14), 75112 (7/14), 76827 (8/14), 77881 (8/14), 78490 (8/14), 78996 (9/14), 80010 (9/14), 80112 (9/14), 81579 (10/14), 82411 (10/14), 83477 (1/15), 84095 (1/15), 84096 (1/15), 140484 (1/15), 140767 (1/15), 141270 (2/15), 141758 (1/15), 142315 (3/15), 142867 (3/15), 143367 (3/15), 143755 (3/15), 144067 (3/15), 144552 (3/15), 144791 (3/15), 145197 (3/15), 146104 (3/15), 146340 (6/15), 147439 (6/15), 147654 (3/15), 148584 (6/15), 149826 (8/15), 150417 (9/15), 151242 (10/15), 152072 (10/15), 152075 (10/15), 152428 (11/15), 152929 (11/15), 156099 (2/16). Family Wellness O) 72620 (5/14), 72826 (5/14), 73026 (5/14), 74080 (6/14), 74764 (6/14), 75115 (7/14), 75409 (7/14), 76988 (8/14), 77492 (8/14), 77492 (8/14), 77808 (8/14), 77809 (8/14), 77810 (8/14), 78165 (9/14), 78550 (9/14), 78823 (9/14), 78824 (9/14), 78918 (9/14), 79491 (9/14), 79734 (9/14), 79735 (10/14), 79736 (10/14), 80086 (10/14), 80753 (10/14), 80754 (10/14), 81330 (10/14), 83218 (1/15), 83480 (1/15), 83684 (1/15), 133190 (1/15), 140366 (1/15), 141557 (2/15), 143346 (3/15), 143788 (3/15), 143844 (3/15), 145267 (3/15), 146107 (6/15), 146960 (6/15), 147438 (6/15), 148175 (6/15), 148289 (6/15), 149094 (6/15), 149095 (7/15), 149281 (7/15), 149827 (8/15), 150310 (9/15), 151063 (10/15), 151064 (10/15), 151369 (10/15), 151370 (10/15), 151833 (10/15), 151834 (10/15), 151902 (10/15), 151903 (10/15), 152867 (11/15), 153245 (11/15), 153839 (12/15), 154022 (12/15), 154494 (12/15). P) Fred's: 74155 (6/14), 75343 (6/14), 79119 (9/14), 81070 (10/14), 81782 (10/14), 83844 (1/15), 141265 (1/15), 142813 (3/15), 144463 (3/15), 144792 (3/15), 145061 (3/15), 145473 (3/15), 150309 (9/15), 152292 (10/15), 152293 (10/15), 153836 (11/15), 156097 (1/14). Laura Lynn Q) 75982 (5/14), 77876 (7/14), 140396 (1/15), 151059 (8/15), 152787 (8/15), 153070 (8/15), 153205 (8/15), 153901 (12/15), 155627 (12/15), 155791 (12/14). LiveBetter R-S) 71902 (5/14), 72825 (5/14), 73892 (5/14), 73979 (6/14). Marc's T) 73981 (6/14), 140160 (1/15), 144514 (3/15), 146639 (3/15), 146641 (6/15). 666 COLD U-V) 78951 (8/14), 81716 (10/14), 81868 (10/14), 141028 (8/14), 141032 (12/14), 141756 (12/14), 141757 (2/15), 145551 (12/14), 147710 (12/14), 149093 (7/15), 151328 (7/15), 151619 (10/15). Our Family W-X) 78802 (9/14), 80662 (10/14), 82458 (12/14), 82569 (12/14), 84097 (1/15), 142342 (2/15), 145770 (2/15), 146105 (2/15), 150010 (8/15), 151372 (10/15), 152523 (11/15), 7205001 (5/14), 7788201 (8/14). Premier Value Y-AA) 72618 (5/14), 73893 (5/14), 73980 (6/14), 74763 (5/14), 75903 (5/14), 75904 (6/14), 75905 (6/14), 75906 (6/14), 75907 (6/14), 76255 (7/14), 77877 (7/14), 77883 (8/14), 78793 (7/14), 79670 (7/14), 81068 (11/14), 81119 (10/14), 81261 (9/14), 81775 (11/14), 82075 (11/14), 82125 (10/14), 82716 (11/14), 83216 (1/15), 83478 (1/15), 140485 (1/15), 142147 (3/15), 142496 (1/15), 143345 (1/15), 145207 (1/15), 145936 (1/15), 145937 (3/15), 147253 (3/15), 147262 (2/15), 147365 (2/15), 153837 (11/15), 153903 (10/15), 155861 (12/15). Publix BB) 71959 (4/15), 72475 (5/14), 72619 (5/14), 74086 (6/14), 75184 (7/14), 77889 (8/14), 77890 (9/14), 79492 (6/14), 79493 (7/14), 79494 (7/14), 79495 (9/14), 79496 (9/14), 141348 (2/15), 142268 (3/15), 142665 (1/15), 142666 (2/15), 142667 (3/15), 142668 (3/15), 142751 (3/15), 147094 (6/15), 147432 (9/14), 147436 (3/15), 147437 (3/15), 147893 (6/15), 149405 (8/15), 149828 (8/15), 151371 (10/15), 152668 (11/15), 153828 (11/15), 154232 (12/15), 154783 (12/15), 155383 (1/16), 155470 (1/14), 155471 (1/14), 156098 (1/14), 7261901 (5/14). Quality Choice CC-EE) 148333 (8/15), 148335 (2/15), 148555 (2/15), 149817 (8/15), 149819 (8/15), 149967 (9/15), 150011 (8/15), 150071 (9/15), 150312 (8/15), 150786 (9/15), 150860 (9/15), 152868 (11/15), 154234 (12/15), 155476 (1/14), 7190301 (5/14), 7239801 (5/14), 7444801 (6/14), 7458901 (6/14), 7788701 (8/14), 7879701 (9/14), 8030901 (10/14), 8075501 (10/14), 8186901 (10/14), 8231001 (10/14), 8321701 (12/14), 8368301 (12/14), 8368301 (1/15), 8384501 (1/15), 14112301 (1/15), 14640501 (6/15), 14761401 (4/15), 14848401 (6/15), 15106201 (10/15). RiteAid FF-II) 72517 (5/14), 72728 (5/14), 73745 (6/14), 74333 (6/14), 74973 (5/14), 75298 (5/15), 76137 (5/14), 76712 (8/14), 76828 (8/14), 77316 (8/14), 77504 (8/14), 80201 (8/14), 80202 (10/14), 80756 (10/14), 80848 (10/14), 81426 (10/14), 81427 (11/14), 81714 (10/14), 81878 (11/14), 81932 (12/14), 82009 (10/14), 143601 (3/15), 143843 (3/15), 144668 (2/15), 144953 (3/15), 144954 (2/15), 145169 (3/15), 145266 (3/15), 145660 (2/15), 146677 (3/15), 146678 (2/15), 146959 (3/15), 147186 (2/15), 147206 (2/15), 147774 (2/15), 147776 (2/15), 148098 (2/15), 148099 (2/15), 148174 (8/15), 148334 (8/15), 149966 (9/15), 150743 (9/15), 151997 (10/15), 152094 (9/15), 152095 (10/15), 152427 (11/15), 153588 (11/15), 154233 (12/15), Safeway JJ) 76406 (8/14), 76407 (8/14), 7732801 (8/14), 7801301 (8/14), 7801401 (8/15), 7801501 (8/14), 7853901 (9/14), 7973701 (10/14), 7973801 (10/14), 8008701 (10/14), 8050601 (10/14), 8088801 (10/14), 8116101 (10/14), 8133201 (10/14), 8200801 (12/14), 8212601 (10/14), 8223401 (12/14), 8231101 (12/14), 8257001 (12/14), 8282701 (12/14), 8394401 (1/15), 14016101 (1/15), 14083101 (2/15), 14127101 (2/15), 14141701 (2/15), 14155801 (2/15), 14336801 (2/15), 14584601 (2/15), 14584701 (2/15), 14935801 (2/15), 14935901 (8/15), 14961101 (8/15), 14968401 (8/15), 14985301 (8/15), 15031101 (8/15), 15078701 (9/15), 15132901 (10/15), 15194101 (10/15), 15218301 (10/15), 15408201 (12/15), 15438501 (12/15), 15468101 (12/15), 15495801 (1/16), 15547301 (1/14), Select Brand KK-LL) 74676 (5/14), 75144 (7/14), 76711 (7/14), 77878 (7/14), 77884 (8/14), 78549 (8/14), 78800 (9/14), 79207 (7/14), 79446 (7/14), 80471 (9/14), 82593 (10/14), 83125 (12/14), 83453 (11/14), 140159 (1/15), 140397 (1/15), 140757 (1/15), 140766 (1/15), 144790 (1/15), 147362 (1/15), 151061 (10/15), 152522 (8/15), 152644 (8/15), 152928 (12/15), 153902 (12/15), ShopRite MM) 77885 (8/14), 79120 (9/14), 79447 (6/14), 81940 (10/14), 82412 (10/14), Western Family NN) 145421 (2/15), 146805 (2/15), 155954 (1/16).
Quantity recalled2,500,510 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-1254-2014
FDA event ID
68018
Recalling firm
P&L Developments, Lynwood, CA
Classification
Class III
Status
Terminated
Recall initiated
14 Apr 2014
FDA classified
22 Apr 2014
Reported
30 Apr 2014
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Foreign Material
Drug class
Pain Medication

Timeline

14 Apr 2014Recall initiated by company
22 Apr 2014Classified by FDA+8 days
30 Apr 2014Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subpotent Drug: Phenylephrine component is subpotent.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron Health, 8 FL OZ, Manufactured by: PL Developments, 11865 S. Alameda St, Lynwood, CA 90262, UPC: 7 15256 71428 0; C) Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73506 3; D) Aaron Health, 4 FL OZ, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73504 9; E) Best Choice, 6 FL OZ, Proudly Distributed By: Valu Merchandisers, CO., Kansas City, MO 64111, UPC: 0 70038 61984 0 F) Best Choice, 10 FL OZ, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC: 0 70038 61985; G) CareOne, 10 FL OZ, Distributed By American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31853 5; H) CareOne, 12 FL OZ, Distributed By: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086, UPC: 3 41520 31832 0; I) drug mart, 10 FL OZ, Distributed By: Discount Drug Mart-Food Fair, Medina, Ohio 44256, NDC: 93351-0142-1; J) DR, 6 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04479; K) DR, 10 FL OZ, Distributed by DUANEreade, 440 Ninth Avenue, NY, NY 10001, UPC: 6 39194 04480 6; L) equate, 10 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-01; M) equate: 12 FL OZ, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC: 49035-142-02; N) exchange select, 10 FL OZ, Manufactured For: Your Military Exchanges, By Aaron Industries Inc., P.O. Box 801, Lynwood CA 90262, UPC: 6 14299 40234 8; O) Family wellness, 10 FL OZ, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105 USA, UPC: 0 32251 00504 6; P) Fred's, 10 FL OZ, Distributed By: Fred's, Inc., 4300 New Getwell Rd, Memphis, TN 38118, UPC: 0 84579 11020 9; Q) Laura Lynn, 6 FL OZ, Distributed by: Ingles Markets, Asheville, NC 28816, UPC: 0 86854 04767 5; R) LiveBetter, 10 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 49580-3416-1; S) LiveBetter, 6 FL OZ, Distributed By Onpoint, Inc., 2 Paragon Drive, Montvale, NJ 07645, NDC: 41310-0142-6; T) Marc's, 10 FL OZ, Distributed by: Marc Glassman Inc. Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; U) 666 COLD Preparation, 4 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00224 3; V) 666 COLD Preparation, 8 FL OZ, Distributed by: Monticello Drug Company, Jacksonville, FL 32204, UPC: 3 11868 00228 1; W) Our Family, 12 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 97109 9; X) Our Family, 10 FL OZ, Distributed By: Nash Finch Company, NFC Brands, 7600 France Ave S, MPLS, MN 55435, UPC: 0 70253 96745 0; Y) Premier Value, 6 FL OZ, Distributed By: Chain Drug Consortium, LLC., 2300 NW Corporate Blvd., Suite 115, Boca Rataon, FL 33431, NDC: 68016-0023-79; Z) Premier Value, 8 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-08; AA) Premier Value, 10 FL OZ, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suit 101, Boca Raton, FL 33431, NDC: 68013-142-01; BB) Publix, 10 FL OZ, Distributed By: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, 0 41415 27073 2; CC) Quality Choice, 8 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novi, MI 48376, NDC: 63868-245-08; DD) Quality Choice, 10 FL OZ, Distributed by Quality Choice, Novi, MI 48376, NDC: 63868-0245-10; EE) Quality Choice, 12 FL OZ, Distributed by C.D.M.A. Inc., 43157 W. Nine Mile, Novli, MI 48376, NDC: 63868-245-12; FF) Rite Aid, 6 FL OZ, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 170

Where it was distributed

Nationwide in US

Nationwide

Stores named: Walmart, Publix, Dollar Tree, Rite Aid

Questions about this recall

Is Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr recalled?

Yes. P&L Developments recalled Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr on 14 Apr 2014. The recall is Class III and its status is Terminated. Recall number D-1254-2014.

Why was it recalled?

Subpotent Drug: Phenylephrine component is subpotent.

Which lots are affected?

Lot # (expiry): Aaron Health A-D) 72493 (5/14), 75241 (7/14), 77879 (8/14), 78795 (9/14), 81058 (11/14), 81118 (10/14), 81578 (10/14), 82076 (10/14), 82023 (11/14), 140756 (1/15), 141655 (11/14), 141882 (3/15), 142086 (2/15), 144257 (1/15), 147361 (3/15), 148288 (6/15), 149143 (7/15), 149512 (7/15), 149741 (8/15), 150307 (9/15), 152290 (3/15), 152666 (11/15), 152752 (8/15), 154931 (10/15), 155111 (1/16). BestChoice E-F) 76825 (7/14), 78792 (7/14), 78798 (9/14), 79357 (6/14), 79732 (9/14), 79733 (9/14), 81066 (11/14), 81695 (10/14), 83452 (12/14), 83682 (1/15), 83843 (1/15), 140395 (1/15), 142314 (3/15), 147440 (1/15), 148095 (6/15), 149404 (8/15), 149445 (8/15), 152521 (8/15), 152521 (8/15), 152866 (8/15), 153069 (8/15), 153900 (12/15), 154463 (12/15), 154919 (12/14), 154957 (1/14). CareOne G-H) 73250 (5/14), 77891 (8/14), 78801 (9/14), 81580 (10/14), 7325001 (5/14), 7397801 (6/14), 7788001 (8/14), 8158001 (10/14), 8321501 (1/15), 14048301 (1/15), 14126901 (2/15). Drug Mart I) 77886 (8/14), 83479 (1/15), 141268 (2/15), 143648 (3/15), 144828 (3/15), 148472 (6/15), 148483 (6/15), 151620 (10/15), 152667 (11/15). Duanereade J-K) 73377 (5/14), 73977 (5/14), 74888 (5/14), 76136 (7/14), 77068 (7/14), 77875 (7/14), 80308 (7/14), 81067 (11/14), 81069 (10/14). Equate L-M) 73736 (6/14), 74386 (6/14), 75111 (7/14), 75824 (7/14), 76826 (8/14), 78210 (9/14), 78417 (9/14), 78457 (9/14), 78858 (9/14), 78859 (9/14), 78860 (9/14), 79182 (10/14), 79564 (10/14), 80310 (10/14), 80311 (10/14), 80312 (10/14), 81071 (10/14), 81184 (11/14), 81331 (11/14), 81931 (12/14), 82010 (12/14), 82533 (12/14), 82913 (12/14), 83797 (12/14), 83798 (12/14), 83799 (12/14), 83943 (1/15), 84098 (1/15), 140937 (2/15), 141126 (2/15), 141127 (2/15), 141204 (2/15), 141831 (2/15), 143619 (2/15), 145776 (2/15), 146377 (2/15), 146766 (2/15), 147479 (2/14), 148254 (2/15), 148733 (8/15), 148876 (2/15), 148877 (2/15), 149282 (8/15), 149497 (8/15), 150586 (8/15), 150922 (8/15), 150923 (9/15), 151132 (9/15), 151261 (10/15), 152254 (10/15), 152447 (11/15), 152758 (11/15), 152759 (11/15), 153095 (11/15), 153096 (11/15), 153714 (11/15), 154488 (122/15), 154980 (1/16), 155574 (1/16). Exchange Select N) 71901 (5/14), 72662 (5/14), 73737 (6/14), 75112 (7/14), 76827 (8/14), 77881 (8/14), 78490 (8/14), 78996 (9/14), 80010 (9/14), 80112 (9/14), 81579 (10/14), 82411 (10/14), 83477 (1/15), 84095 (1/15), 84096 (1/15), 140484 (1/15), 140767 (1/15), 141270 (2/15), 141758 (1/15), 142315 (3/15), 142867 (3/15), 143367 (3/15), 143755 (3/15), 144067 (3/15), 144552 (3/15), 144791 (3/15), 145197 (3/15), 146104 (3/15), 146340 (6/15), 147439 (6/15), 147654 (3/15), 148584 (6/15), 149826 (8/15), 150417 (9/15), 151242 (10/15), 152072 (10/15), 152075 (10/15), 152428 (11/15), 152929 (11/15), 156099 (2/16). Family Wellness O) 72620 (5/14), 72826 (5/14), 73026 (5/14), 74080 (6/14), 74764 (6/14), 75115 (7/14), 75409 (7/14), 76988 (8/14), 77492 (8/14), 77492 (8/14), 77808 (8/14), 77809 (8/14), 77810 (8/14), 78165 (9/14), 78550 (9/14), 78823 (9/14), 78824 (9/14), 78918 (9/14), 79491 (9/14), 79734 (9/14), 79735 (10/14), 79736 (10/14), 80086 (10/14), 80753 (10/14), 80754 (10/14), 81330 (10/14), 83218 (1/15), 83480 (1/15), 83684 (1/15), 133190 (1/15), 140366 (1/15), 141557 (2/15), 143346 (3/15), 143788 (3/15), 143844 (3/15), 145267 (3/15), 146107 (6/15), 146960 (6/15), 147438 (6/15), 148175 (6/15), 148289 (6/15), 149094 (6/15), 149095 (7/15), 149281 (7/15), 149827 (8/15), 150310 (9/15), 151063 (10/15), 151064 (10/15), 151369 (10/15), 151370 (10/15), 151833 (10/15), 151834 (10/15), 151902 (10/15), 151903 (10/15), 152867 (11/15), 153245 (11/15), 153839 (12/15), 154022 (12/15), 154494 (12/15). P) Fred's: 74155 (6/14), 75343 (6/14), 79119 (9/14), 81070 (10/14), 81782 (10/14), 83844 (1/15), 141265 (1/15), 142813 (3/15), 144463 (3/15), 144792 (3/15), 145061 (3/15), 145473 (3/15), 150309 (9/15), 152292 (10/15), 152293 (10/15), 153836 (11/15), 156097 (1/14). Laura Lynn Q) 75982 (5/14), 77876 (7/14), 140396 (1/15), 151059 (8/15), 152787 (8/15), 153070 (8/15), 153205 (8/15), 153901 (12/15), 155627 (12/15), 155791 (12/14). LiveBetter R-S) 71902 (5/14), 72825 (5/14), 73892 (5/14), 73979 (6/14). Marc's T) 73981 (6/14), 140160 (1/15), 144514 (3/15), 146639 (3/15), 146641 (6/15). 666 COLD U-V) 78951 (8/14), 81716 (10/14), 81868 (10/14), 141028 (8/14), 141032 (12/14), 141756 (12/14), 141757 (2/15), 145551 (12/14), 147710 (12/14), 149093 (7/15), 151328 (7/15), 151619 (10/15). Our Family W-X) 78802 (9/14), 80662 (10/14), 82458 (12/14), 82569 (12/14), 84097 (1/15), 142342 (2/15), 145770 (2/15), 146105 (2/15), 150010 (8/15), 151372 (10/15), 152523 (11/15), 7205001 (5/14), 7788201 (8/14). Premier Value Y-AA) 72618 (5/14), 73893 (5/14), 73980 (6/14), 74763 (5/14), 75903 (5/14), 75904 (6/14), 75905 (6/14), 75906 (6/14), 75907 (6/14), 76255 (7/14), 77877 (7/14), 77883 (8/14), 78793 (7/14), 79670 (7/14), 81068 (11/14), 81119 (10/14), 81261 (9/14), 81775 (11/14), 82075 (11/14), 82125 (10/14), 82716 (11/14), 83216 (1/15), 83478 (1/15), 140485 (1/15), 142147 (3/15), 142496 (1/15), 143345 (1/15), 145207 (1/15), 145936 (1/15), 145937 (3/15), 147253 (3/15), 147262 (2/15), 147365 (2/15), 153837 (11/15), 153903 (10/15), 155861 (12/15). Publix BB) 71959 (4/15), 72475 (5/14), 72619 (5/14), 74086 (6/14), 75184 (7/14), 77889 (8/14), 77890 (9/14), 79492 (6/14), 79493 (7/14), 79494 (7/14), 79495 (9/14), 79496 (9/14), 141348 (2/15), 142268 (3/15), 142665 (1/15), 142666 (2/15), 142667 (3/15), 142668 (3/15), 142751 (3/15), 147094 (6/15), 147432 (9/14), 147436 (3/15), 147437 (3/15), 147893 (6/15), 149405 (8/15), 149828 (8/15), 151371 (10/15), 152668 (11/15), 153828 (11/15), 154232 (12/15), 154783 (12/15), 155383 (1/16), 155470 (1/14), 155471 (1/14), 156098 (1/14), 7261901 (5/14). Quality Choice CC-EE) 148333 (8/15), 148335 (2/15), 148555 (2/15), 149817 (8/15), 149819 (8/15), 149967 (9/15), 150011 (8/15), 150071 (9/15), 150312 (8/15), 150786 (9/15), 150860 (9/15), 152868 (11/15), 154234 (12/15), 155476 (1/14), 7190301 (5/14), 7239801 (5/14), 7444801 (6/14), 7458901 (6/14), 7788701 (8/14), 7879701 (9/14), 8030901 (10/14), 8075501 (10/14), 8186901 (10/14), 8231001 (10/14), 8321701 (12/14), 8368301 (12/14), 8368301 (1/15), 8384501 (1/15), 14112301 (1/15), 14640501 (6/15), 14761401 (4/15), 14848401 (6/15), 15106201 (10/15). RiteAid FF-II) 72517 (5/14), 72728 (5/14), 73745 (6/14), 74333 (6/14), 74973 (5/14), 75298 (5/15), 76137 (5/14), 76712 (8/14), 76828 (8/14), 77316 (8/14), 77504 (8/14), 80201 (8/14), 80202 (10/14), 80756 (10/14), 80848 (10/14), 81426 (10/14), 81427 (11/14), 81714 (10/14), 81878 (11/14), 81932 (12/14), 82009 (10/14), 143601 (3/15), 143843 (3/15), 144668 (2/15), 144953 (3/15), 144954 (2/15), 145169 (3/15), 145266 (3/15), 145660 (2/15), 146677 (3/15), 146678 (2/15), 146959 (3/15), 147186 (2/15), 147206 (2/15), 147774 (2/15), 147776 (2/15), 148098 (2/15), 148099 (2/15), 148174 (8/15), 148334 (8/15), 149966 (9/15), 150743 (9/15), 151997 (10/15), 152094 (9/15), 152095 (10/15), 152427 (11/15), 153588 (11/15), 154233 (12/15), Safeway JJ) 76406 (8/14), 76407 (8/14), 7732801 (8/14), 7801301 (8/14), 7801401 (8/15), 7801501 (8/14), 7853901 (9/14), 7973701 (10/14), 7973801 (10/14), 8008701 (10/14), 8050601 (10/14), 8088801 (10/14), 8116101 (10/14), 8133201 (10/14), 8200801 (12/14), 8212601 (10/14), 8223401 (12/14), 8231101 (12/14), 8257001 (12/14), 8282701 (12/14), 8394401 (1/15), 14016101 (1/15), 14083101 (2/15), 14127101 (2/15), 14141701 (2/15), 14155801 (2/15), 14336801 (2/15), 14584601 (2/15), 14584701 (2/15), 14935801 (2/15), 14935901 (8/15), 14961101 (8/15), 14968401 (8/15), 14985301 (8/15), 15031101 (8/15), 15078701 (9/15), 15132901 (10/15), 15194101 (10/15), 15218301 (10/15), 15408201 (12/15), 15438501 (12/15), 15468101 (12/15), 15495801 (1/16), 15547301 (1/14), Select Brand KK-LL) 74676 (5/14), 75144 (7/14), 76711 (7/14), 77878 (7/14), 77884 (8/14), 78549 (8/14), 78800 (9/14), 79207 (7/14), 79446 (7/14), 80471 (9/14), 82593 (10/14), 83125 (12/14), 83453 (11/14), 140159 (1/15), 140397 (1/15), 140757 (1/15), 140766 (1/15), 144790 (1/15), 147362 (1/15), 151061 (10/15), 152522 (8/15), 152644 (8/15), 152928 (12/15), 153902 (12/15), ShopRite MM) 77885 (8/14), 79120 (9/14), 79447 (6/14), 81940 (10/14), 82412 (10/14), Western Family NN) 145421 (2/15), 146805 (2/15), 155954 (1/16).

Where was it sold?

Nationwide in US

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from P&L Developments

All 2
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIIChildren's Triacting Night Time Cold & Cough with PE recalledP&L DevelopmentsForeign MaterialNationwide