FDA Recalls Vancomycin HCl Due to Missing Stability Data
American Pharmaceutical Ingredients is recalling Vancomycin HCl 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 indicates a reasonable probability of temporary or medically reversible health consequences. The hazard is a documentation and stability data deficiency rather than a confirmed contamination or acute safety defect, fitting the Moderate severity criteria for minor labeling or documentation issues.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Vancomycin HCl USP for prescription compounding, manufactured by American Pharmaceutical Ingredients LLC. The affected product is available in 25g, 100g, and 500g packages and is distributed nationwide within the United States. The specific lot number for all package sizes is 013117-1, with an expiration date of 06/30/2019.
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/closure system. This means the product's shelf life and safety over time have not been adequately verified.
Healthcare providers and pharmacies should stop using the affected lots immediately. Consumers who have purchased this prescription-only medication should contact their healthcare provider or pharmacist for guidance on how to dispose of or replace the product. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4); b) 100g (NDC 58597-8091-6); c) 500g (NDC 58597-8091-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Antibiotic
- Affected units
- 12,725
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) 013117-1
- Exp. 06/30/2019
- b) 013117-1
- c) 013117-1
- Exp. 06/30/2019.
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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