American Pharmaceutical Ingredients Recalls Nifedipine USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Nifedipine 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 situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a documentation and stability data deficiency rather than a confirmed contamination or acute injury risk.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Nifedipine USP for prescription compounding. The product is available in 5g, 25g, 100g, and 500g packages and is intended for prescription use only. The recall covers specific lots with expiration dates of 12/04/2018.
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.
The affected product was distributed nationwide within the USA. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), 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
- 44,500
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 (7)
- Lot #: a) 020615-2
- Exp. 12/04/2018
- b) 020615-2
- c) 020615-1
- d) 020615-1
- 020615-2
- Exp. 12/04/2018.
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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