CLASS II Drug recall · Reported 22 Aug 2012 · FDA Enforcement Report

Mic - Combo With Methylcobalamin 0.8/1.6/1.6/0.0001/0.03% recalled

Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling Mic - Combo With Methylcobalamin 0.8/1.6/1.6/0.0001/0.03% Injectable kits, distributed nationwide in the US. The recall was initiated on 21 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRx #'s: 0406657 0405526 0391965 0393529 0390040 0362442 0370756 0378145 0386548 0393611 0394410 0394751 0394753 0395981 0397434 0398818 0399650 0399825 0399848 0399854 0400112 0401949 0404137 0404138 0404295 0405528 0405700 0407504 0407507 0407770 0408225 0408229 0408670 0410088 0370756 0376063 0391443 0397137 0397222 0397227 0402055 0406817 0391443 0362442 0375777 0390216 0392072 0392079 0392091 0395270 0395277 0395284 0398284 0400112 0403421 0370756 0391443 0362395 0374541 0375777 0395538 0407969 0391443 0374541 0376063 0395987 0395989 0397137 0402055 0387769 0370756 0374541 0376063 0374541 0383057 0385833 0387137 0387361 0387564 0387810 0388478 0390588 0391303 0392314 0392586 0393046 0393339 0394113 0394120 0395617 0395663 0395677 0396139 0397002 0397162 0397275 0397424 0397438 0397462 0397528 0397934 0398287 0398574 0398695 0398774 0399172 0399416 0399658 0399659 0399766 0399862 0400268 0400583 0400688 0400834 0401416 0401429 0401445 0401476 0401499 0401683 0401771 0402350 0403007 0403151 0403488 0403593 0403594 0403874 0404051 0404293 0404566 0404649 0404671 0404837 0404856 0404868 0404916 0405436 0405907 0405938 0406152 0406239 0406886 0407034 0407563 0408732 0381970 0388666 0402009 0376106 0393514 0405150
Quantity recalled188 units

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-1579-2012
FDA event ID
62443
Classification
Class II
Status
Terminated
Recall initiated
21 May 2012
FDA classified
10 Aug 2012
Reported
22 Aug 2012
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

21 May 2012Recall initiated by company
10 Aug 2012Classified by FDA+81 days
22 Aug 2012Published in enforcement report+12 days

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

Reason for recall

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL 10 VIAL 15 VIAL 2 VIAL 20 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 6 VIAL 7 VIAL 8 VIAL MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) 10,000 UNIT VIAL INJECTABLE 1 KIT 2 KIT 4 KIT MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) II 10,000 UNIT VIAL INJECTA 1 KIT (20 DIFFERENT PRODUCTS)

Where it was distributed

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Which lots are affected?

Rx #'s: 0406657 0405526 0391965 0393529 0390040 0362442 0370756 0378145 0386548 0393611 0394410 0394751 0394753 0395981 0397434 0398818 0399650 0399825 0399848 0399854 0400112 0401949 0404137 0404138 0404295 0405528 0405700 0407504 0407507 0407770 0408225 0408229 0408670 0410088 0370756 0376063 0391443 0397137 0397222 0397227 0402055 0406817 0391443 0362442 0375777 0390216 0392072 0392079 0392091 0395270 0395277 0395284 0398284 0400112 0403421 0370756 0391443 0362395 0374541 0375777 0395538 0407969 0391443 0374541 0376063 0395987 0395989 0397137 0402055 0387769 0370756 0374541 0376063 0374541 0383057 0385833 0387137 0387361 0387564 0387810 0388478 0390588 0391303 0392314 0392586 0393046 0393339 0394113 0394120 0395617 0395663 0395677 0396139 0397002 0397162 0397275 0397424 0397438 0397462 0397528 0397934 0398287 0398574 0398695 0398774 0399172 0399416 0399658 0399659 0399766 0399862 0400268 0400583 0400688 0400834 0401416 0401429 0401445 0401476 0401499 0401683 0401771 0402350 0403007 0403151 0403488 0403593 0403594 0403874 0404051 0404293 0404566 0404649 0404671 0404837 0404856 0404868 0404916 0405436 0405907 0405938 0406152 0406239 0406886 0407034 0407563 0408732 0381970 0388666 0402009 0376106 0393514 0405150

Where was it sold?

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

97 other products · FDA event 62443

This product is part of a recall event; the main page for the event is Tobramycin 1.4% (14mg/ML) Ophthalmic recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IITobramycin 1.4% (14mg/ML) Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILissamine Green Solution 1% Ophthalmic (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILidocaine HCL (sterile) 4% Jelly recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMannitol 20% Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITestosterone Cyp/estradiol Cyp 50mg/2mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIStrontium 1 MG/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITriamcinolone Acetonide 4mg/ML recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMolybdenum 250mcg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IINadh-ffc 10 MG/cc Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPapaverine HCL ** Vial) 30mg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIIopamidol 41% Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMethylcobalamin 1,000mcg/ML Injectable 26 Mls 30 Mls recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITrocar Kit, Sterile Disposable** Device 1 Kit 1 Pellet recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPovidone-iodine Ophthalmic 5% Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILidocaine/sodium Bicarbonate/heparin Irrigation recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIIsosulfan Blue 1% Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIProcaine HCL, P.f. 1% Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMagnesium Chloride, Preservative Free 20% Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPapaverine/phentolamine/atropine Ns 3.6mg/0.4mg/0.04mg recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMitomycin 1mg/ML Solution recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPapaverine/alprostadil 30mg/10mcg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIOndansetron HCL, Mdv 2mg/ML (40mg/ Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIUltra-test 200 (cyp 80%/prop 20%) 200mg/ML Injectable 10 Mls 20 Mls recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMethionine/inositol/choline Chloride/chrom/b12 recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IISodium Bicarbonate 4% Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIVoriconazole Ophthalmic 1% (10mg/ML) Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIVerapamil HCL 10mg/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILorazepam 2mg/ML Injectable (3 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITetracaine HCL Ophthalmic 0.05% Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPhenylephrine/tropicamide (p.f.) Solution 2.5%/1% recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITrypan Blue Solution, P.f. 0.04% Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMethylcobalamin/folic Acid - Kit 10mg/0.4mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITetracosactide Acetate (cosyntropin) 0.25mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIInsulin, Lo-dose (from Humalog)/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIRiboflavin Solution 0.1% Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILevothyroxine Sodium 325mcg/ML (0.325mg/ML) Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMitomycin/bupivacaine With Epi 1:200 recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITaurine 50mg/ML Injectable (4 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIL-arginine 500mg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIVancomycin (intraocular) Ophthalmic, P.f. (bss) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPyridoxine 100mg/ML Injectable (5 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIIohexol 200mg Iodine/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPhenyleph/diclof/tropic/proparac/povidone Iodine Sol recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPenicillin G Potassium 10,000u/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITwinject*** 0.3 MG Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIVancomycin/dexamethasone, Lyophilized 1%/0.1% Kit 2 Kit recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMitomycin/lidocaine/epinephrine 0.04%/0.02%/0.1% Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIVanadyl Sulfate Solution 200mcg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMoxifloxacin 150mcg/ (1.5mg/ML) Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMidazolam 1mg/ML Vial) Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIWater Bact Sterile - (25x30ml)*** Injectable 750 Mls recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIVitamin K (phytonadione) 10mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPhentolamine 10mg/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILeucovorin, Lyophilized 100 MG Vial Injectable 1 Vial recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPhenylephrine/tropicamide/proparacaine Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMepivacaine HCL/epinephrine recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIL-tryptophan 15mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMetoclopramide HCL 5mg/ML (10mg/ Injectable (9 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILithium Chloride 5mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IISesame Ophthalmic Oil (1 Product) recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMeyers Cocktail Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIKenalog-40** (mdv Vial) 40mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITropicamide Ophthalmic P.f. 1% Solution (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IISelenium 200mcg/ML Injectable (3 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIKetorolac Tromethamine 30mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IINandrolone Decanoate (h) 200mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILabetalol Hydrochloride 5mg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILidocaine HCL/epinephrine In Bss - P.f. recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITropicamide/phenylephrine Ophthalmic 15:1 Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPilocarpine HCL P.f In B.s.s Ophthalmic 1% Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPhenylephrine HCL In Bss - P.f. Ophthalmic 1% Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPotassium Chloride *** Vial) 2meq/ML Injectable 750 Mls recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IISermorelin Acetate, Lyophilized 6mg Kit 1 Kit 2 Kit recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILidocaine/tetracaine Ophthalmic 4%/0.5% Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITrimix 9mg / 0.3mg /3.3mcg Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPrednisolone Acetate 10mg/ML Injectable 10 Mls (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIThiotepa, Lyophilized 15mg Injectable 8 Vial recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPaclitaxel 6mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIQuadmix 12mg/1mg/10mcg/150mcg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIZinc Chloride 10mg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITheracys, (bcg Vaccine) Live W/diluent** 81mg Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMorphine Sulfate 2mg/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIProgesterone Aqueous 2mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILevofloxacin, P.f. (premixed Solution) 5mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIRubidium 200mcg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMethionine / Inositol / Choline Chloride 25mg/75mg/75mg/ML recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPantothenic Acid 1mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIRanitidine 25mg/ML Injectable (3 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPovidone-iodine/lidocaine/tetracaine 4.6%/4%/0.5% recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIRanibizumab, Sdpf - Syringe, 5/16") 10mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITrimix/lidocaine 11.8mg/0.39mg/10.6mcg/1.7mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILidocaine HCL/bupivacaine HCL Pf 1%/0.375% Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIThiamine HCL 100mg/ML Injectable (3 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIOxytocin/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMethylprednisolone Acetate 100mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILidocaine/epinephrine/bupivacaine, Pf 1%/0.00025%/0.375% Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMethylprednisolone Acetate/lidocaine HCL 40mg/10mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide

More recalls from Franck's Lab Inc., d.b.a. Franck's Compounding Lab

All 198