US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 21, 2012 (14 years ago)

Methylcobalamin 1,000mcg/Ml Injectable 10 Ml 12 Ml 15 Ml 150…

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

What was recalled

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)

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-1573-2012

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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