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

Methylcobalamin 1,000mcg/ML Injectable 26 Mls 30 Mls recalled

Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling Methylcobalamin 1,000mcg/ML Injectable 26 Mls 30 Mls, 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: 0391301 0391927 0397282 0399470 0391327 0392711 0394996 0401004 0395010 0388696 0389279 0401772 0402650 0404045 0404779 0406029 0408374 0403432 0392999 0395958 0396932 0398177 0405143 0405968 0407753 0365101 0365105 0365106 0365108 0371252 0371257 0371265 0371268 0371270 0382419 0391063 0391522 0393199 0403490 0406625 0406627 0406630 0409573 0409579 0409599 0403432 0387860 0388243 0389493 0390022 0390530 0391010 0391294 0391645 0392576 0392665 0392688 0392894 0393040 0393092 0393216 0393335 0393561 0393731 0395678 0396033 0397292 0398299 0398311 0399018 0400098 0400351 0400429 0400575 0400578 0400982 0401079 0401385 0401646 0401948 0402176 0402516 0402557 0402580 0402987 0403982 0405357 0405430 0405445 0407384 0407808 0407965 0408244 0408382 0408419 0408726 0408792 0409348 0381200 0361853 0392328 0394367 0399209 0390487 0391522 0397635 0381200 0380708 0352927 0361537 0367181 0371957 0373468 0375263 0376692 0378305 0381683 0382865 0384081 0385565 0387059 0387814 0388443 0388942 0388944 0389430 0391105 0397310 0400625 0402660 0403566 0407971 0407993 0388536 0388536 0368410 0388443 0396037 0397310 0400776 0404858 0405790 0404952 0369001 0367492 0400900 0371731 0371731 0371731 0400549 0406613 0392439 0392439 0401628 0392136
Quantity recalled208 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-1573-2012
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

METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 ML 12 ML 15 ML 150 ML 2 ML 26 MLS 3 ML 30 ML 30 MLS 4 ML 40 ML 5 ML 6 ML 60 ML 80 ML 90 ML; METHYLCOBALAMIN ( DR HALL KIT) 1,000MCG/ML INJECTABLE 1 KIT 1 ML 10 ML 30 ML; METHYLCOBALAMIN ( DR HALL KIT) PRESERVATIVE FREE 1,000MCG/ML INJECTABLE 1 KIT; METHYLCOBALAMIN (PRESERV FREE) 1,000MCG/ML INJECTABLE 4 ML 8 ML; METHYLCOBALAMIN (PRESERV FREE) 25,000MCG/ML INJECTABLE 1.5 ML 3 ML 3.5 ML 60 ML; METHYLCOBALAMIN (PRESERVATIVE FREE) 25MG/ML INJECTABLE 30 ML 4 ML 8 ML; METHYLCOBALAMIN 5,000MCG/ML INJECTABLE 6 ML (31 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: 0391301 0391927 0397282 0399470 0391327 0392711 0394996 0401004 0395010 0388696 0389279 0401772 0402650 0404045 0404779 0406029 0408374 0403432 0392999 0395958 0396932 0398177 0405143 0405968 0407753 0365101 0365105 0365106 0365108 0371252 0371257 0371265 0371268 0371270 0382419 0391063 0391522 0393199 0403490 0406625 0406627 0406630 0409573 0409579 0409599 0403432 0387860 0388243 0389493 0390022 0390530 0391010 0391294 0391645 0392576 0392665 0392688 0392894 0393040 0393092 0393216 0393335 0393561 0393731 0395678 0396033 0397292 0398299 0398311 0399018 0400098 0400351 0400429 0400575 0400578 0400982 0401079 0401385 0401646 0401948 0402176 0402516 0402557 0402580 0402987 0403982 0405357 0405430 0405445 0407384 0407808 0407965 0408244 0408382 0408419 0408726 0408792 0409348 0381200 0361853 0392328 0394367 0399209 0390487 0391522 0397635 0381200 0380708 0352927 0361537 0367181 0371957 0373468 0375263 0376692 0378305 0381683 0382865 0384081 0385565 0387059 0387814 0388443 0388942 0388944 0389430 0391105 0397310 0400625 0402660 0403566 0407971 0407993 0388536 0388536 0368410 0388443 0396037 0397310 0400776 0404858 0405790 0404952 0369001 0367492 0400900 0371731 0371731 0371731 0400549 0406613 0392439 0392439 0401628 0392136

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 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 IIMic - Combo With Methylcobalamin 0.8/1.6/1.6/0.0001/0.03% 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

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