American Pharmaceutical Ingredients Recalls Celecoxib USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Celecoxib USP for prescription compounding because the manufacturer lacked stability data to support the assigned 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 deficiency rather than a direct contamination or acute injury risk, fitting the Moderate severity criteria for minor labeling or documentation issues.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Celecoxib USP for prescription compounding. The affected product is packaged in 25g, 100g, and 1000g containers and is available by prescription only. The recall involves a total quantity of 48,525 grams of the product.
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 retest or expiration dates assigned to the product in its container/closure system. The affected lots are 080515-2, 080515-1, and 080515-1, all with an expiration date of 06/05/2019.
The product was distributed nationwide within the United States. Consumers and healthcare providers should stop using the affected lots and return them to the point of purchase or contact the recalling firm for instructions.
The recalled product
- Product
- Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), 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
- 48,525
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) 080515-2
- Exp. 06/05/2019
- b) 080515-1
- c) 080515-1
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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