Agency classClass IIOur severity:Severe FDA (Drugs)·D-1573-2012·Announced 2012-08-22

Franck's Lab Recalls Sterile Methylcobalamin Injectable Due to Sterility Concerns

Franck's Lab Inc. is recalling sterile methylcobalamin injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall with a significant risk of harm (lack of sterility in injectable drugs) corresponds to a severity score of 4 (Severe), as it is not Class I but involves a serious potential for adverse health consequences.

Plain-English summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The recall specifically includes 208 units of various methylcobalamin injectable products, including different concentrations and volumes, as well as Dr. Hall Kit products. These products were distributed nationwide and to several international locations, including the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies.

The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. This lack of assurance of sterility poses a risk to patients who receive these injectable medications.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 ML 12 ML 15 ML 150 ML 2 ML 26 MLS 3 ML 30 ML 30 MLS…
Manufacturer: Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Category: Drug — Injectable Sterile Drug
Hazard: microbial-contamination
fungal-growth
sterility-failure
Affected units: 208

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 98 recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 98 products in this recall →

Same manufacturer · Franck's Lab Inc., d.b.a. Franck's Compounding Lab

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Same hazard · microbial contamination