FDA Recalls Vitamin B12 Compounding Ingredient Due to Stability Data Gaps
American Pharmaceutical Ingredients LLC is recalling Cyanocobalamin USP for prescription compounding because it lacks stability data to support its expiration dates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a reasonable probability of temporary or medically reversible health consequences. The hazard is a documentation and stability data gap rather than a confirmed contamination or acute injury risk, fitting the Moderate severity criteria for low-risk or precautionary issues.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Cyanocobalamin USP (Vitamin B12) intended for prescription compounding. The product is manufactured by American Pharmaceutical Ingredients LLC and is available in 1g, 5g, 25g, and 100g packages. The recall is limited to specific lot numbers with an expiration date of January 14, 2020.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the assigned retest or expiration dates for the product in its current container and closure system. This deficiency means the product's stability over time has not been adequately verified.
The affected product was distributed nationwide within the United States. Because this is a prescription-only ingredient used for compounding, it is not typically sold directly to consumers. Pharmacies and compounding facilities should stop using the affected lots and follow the recall instructions provided by the manufacturer.
The recalled product
- Product
- Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 58597-8044-1), b) 5g (NDC 58597-8044-2), c) 25g (NDC 58597-8044-4), d) 100g (NDC 58597-8044-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 4832
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #: a) 031815-2
- Exp. 1/14/2020
- b) 031815-2
- c) 031815-2
- d) 031815-1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 66 recalled by American Pharmaceutical Ingredients LLC 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.
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