US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 25, 2012 (14 years ago)

Cyanocobalamin

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was 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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

What was recalled

CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15 ML, 150 ML, 180 ML, 2 ML, 200 ML, 3 ML, 30 ML, 300 ML, 32 ML, 4 ML, 5 ML, 6 ML, 60 ML, 90 ML; CYANOCOBALAMIN **1000MCG/ML INJECTABLE 1000MCG/ML INJECTABLE 30 ML; CYANOCOBALAMIN*** (25X10ML VIAL) 1000MCG/ML INJECTABLE 10 ML, 20 MLS, 40 ML; CYANOCOBALMIN ***(VIT B-12) 25X1ML 1000MCG/ML INJECTABLE 50 MLS (24 DIFFERENT PRODUCTS)

Recalling firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1488-2012

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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