CLASS III Drug recall · Reported 7 May 2014 · FDA Enforcement Report
Children's Triacting Night Time Cold & Cough with PE recalled
P&L Developments is recalling Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and, distributed nationwide in the US. The recall was initiated on 15 Apr 2014 and the FDA has classified it as Class III.
Check your package
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-1298-2014
- FDA event ID
- 68037
- Recalling firm
- P&L Developments, Lynwood, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Apr 2014
- FDA classified
- 1 May 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Foreign Material
- Drug class
- Allergy Medication
Timeline
| 15 Apr 2014 | Recall initiated by company | |
| 1 May 2014 | Classified by FDA | +16 days |
| 7 May 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
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
Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105. UPC: 0 32251 03394 0. C) Good Neighbor Pharmacy. Distributed By: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087. NDC: 24385-121-25. D) Pedia Care. Distributed by Medtech Products Inc., Irvington, NY 10533. UPC: 8 14832 01354 7. E) Quality Choice. Distributed by Quality Choice, Novi, MI 48376-0995. NDC: 63868-0368-04. F) Safeway. Distributed by Safeway Inc. P.O. Box 99, Pleasanton, CA 94566. NDC: 21130-152-04. G) Well at Walgreens. Distributed By: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0152-04.
Where it was distributed
Nationwide in US
Stores named: Albertsons, Dollar Tree, Walgreens
Questions about this recall
Is Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and recalled?
Yes. P&L Developments recalled Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and on 15 Apr 2014. The recall is Class III and its status is Terminated. Recall number D-1298-2014.
Why was it recalled?
Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
Which lots are affected?
Lot # (expiry): Aaron Health A) 73825 (6/14), 74141 (6/14), 74830 (6/14), 74898 (7/14), 75339 (7/14), 75455 (7/14), 78531 (9/14), 79050 (9/14), 79267 (10/14), 80017 (7/14), 80781 (7/14), 81121 (10/14), 82178 (10/14). FAMILY wellness B) 82312 (10/14), 82500 (10/15), 133197 (1/15), 140385 (1/15), 141937 (2/15), 142669 (2/15), 143201 (2/15), 143656 (2/15), 145268 (2/15), 146058 (2/15), 146406 (2/15), 146963 (2/15), 147613 (3/15), 148105 (3/15), 148297 (7/15), 148809 (3/15), 149149 (8/15), 149317 (8/15), 149411 (8/15), 149814 (8/15), 149815 (8/15), 150305 (8/15), 150673 (8/15), 151039 (9/15), 151573 (9/15), 151762 (9/15), 152798 (9/15), 153206 (9/15), 153207 (9/15), 153514 (9/15), 154024 (9/15), 155380 (1/16). Good Neighbor Pharmacy C)141202 (2/15),145249 (2/15), 146425 (2/15). Pedia Care D) 73242 (5/14), 73243 (5/14), 73244 (5/14), 73824 (6/14), 74206 (6/14), 74207 (6/14), 74303 (6/14), 74460 (6/14), 78805 (9/14), 79265 (10/14), 79266 (10/14), 79573 (9/14), 80456 (6/14), 80457 (7/14), 83746 (1/15), 133196 (1/15), 144273 (2/15), 154090 (9/15). Quality Choice E) 79355 (6/14), 133193 (1/15), 149447 (8/15), 152870 (8/15). Safeway F) 74899 (7/14), 75103 (7/14), 78803 (9/14), 79089 (9/14), 79349 (6/14), 79671 (10/14), 80599 (10/14), 81263 (7/14), 81960 (10/14), 82047 (10/14), 83726 (1/15), 133194 (1/15), 140252 (1/15), 141023 (2/15), 141692 (2/15), 142148 (2/15), 142316 (2/15), 143399 (2/15), 145170 (2/15), 145826 (1/15), 145828 (1/15), 145829 (2/15), 147961 (3/15), 150302 (2/15), 150304 (7/15), 150549 (8/15), 150866 (9/15), 151650 (8/15), 151651 (9/15), 151906 (9/15), 154922 (1/16), 154923 (1/16). Well at Walgreens G) 73671 (5/14), 73898 (6/14), 74459 (6/14), 74900 (7/14), 75306 (7/14), 75671 (7/14), 76022 (7/14), 78804 (9/14), 79264 (5/14), 79325 (6/14), 79747 (6/14), 8188401 (7/14), 8195301 (7/14), 8195401 (9/14), 8195501 (10/14), 8200601 (10/14), 8257301 (10/14), 8282601 (10/14), 8374501 (10/14), 13319201 (1/16), 13319501 (1/16), 14096601 (2/15), 14165601 (2/15), 14193601 (2/15), 14726901 (3/15), 14755501 (3/15), 14812901 (3/15), 14824701 (3/15), 14829601 (7/15), 14914401 (8/15), 15074701 (9/15), 15434701 (11/15).
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Day Time Cold & Flu, Multi-Symptom, Non-Drowsy recalled | P&L Developments | Foreign Material | Nationwide |