Flurbiprofen USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients is recalling Flurbiprofen USP for prescription compounding because it lacks stability data to support 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 specific issue is a lack of stability data, which is a quality control deviation rather than a confirmed contamination or acute hazard.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Flurbiprofen USP for prescription compounding. The product is available in 25g, 100g, 500g, and 1000g packages and is distributed nationwide in the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the stability data and controls necessary 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 received the product. Consumers should not use the recalled product and should contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075-7); d) 1000g (NDC 58597-8075-8), 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
- 193,000
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 (14)
- Lot #: a) 062915-2
- Exp. 04/30/2020
- b) 022416-1
- Exp. 11/30/2020
- 062915-2
- exp. 04/30/2020
- 081215-2
- Exp. 06/30/2020
- c) 022416-1
- 062915-1
- 081215-1
- d) 022416-1
- 110415-1
- Exp. 09/30/20120
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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