Lincomycin HCl USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Lincomycin 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, and the source text describes a CGMP deviation regarding stability data without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Lincomycin HCl USP for prescription compounding. The product is available in 100g, 500g, and 1000g packages and is distributed nationwide within the USA. The recall involves specific lots with expiration dates of 09/30/2018.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked stability data and controls to support the assigned retest or expiration dates for the product in its container/closure system.
Healthcare providers and pharmacies should stop using the affected lots. Consumers should not use the product and should contact their healthcare provider for guidance.
The recalled product
- Product
- Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g (NDC 58597-8359-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 22,900
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) 110515-2
- Exp. 09/30/2018
- b) 110515-1
- c) 110515-1
- Exp. 09/30/2018.
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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