Prilocaine HCl USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Prilocaine HCl USP for prescription compounding due to a lack of stability data supporting 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 situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a CGMP deviation regarding stability data, which is a quality control issue rather than a direct contamination or acute safety defect like a structural failure or known pathogen.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Prilocaine HCl USP for prescription compounding. The product is available in 100g, 500g, and 1000g packages and is distributed nationwide within the USA. The specific lot number is 071117-1, with an expiration date of 06/16/2020.
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 container/closure system.
This recall affects pharmacies and compounding facilities that may have purchased this specific lot of Prilocaine HCl USP. Consumers should not use the product and should contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g (NDC 58597-8028-8), 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
- 20,700
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 (4)
- Lot #: a) 071117-1
- Exp. 06/16/2020
- b) 071117-1
- c) 071117-1
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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