Naltrexone HCl USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Naltrexone HCl 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 temporary or medically reversible adverse health consequence. The hazard is a documentation and stability data deficiency rather than a confirmed 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 Naltrexone HCl USP (Dihydrate) for prescription compounding. The product is available in 1g, 5g, 25g, and 100g packages and is intended for prescription use only. The recall covers approximately 7,000 grams of the product, which was distributed nationwide within the United States.
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 lot number is 120916-1, with an expiration date of 10/31/2019.
Healthcare providers and pharmacies should stop using the affected product and contact the recalling firm for instructions on return or disposal. Consumers who have purchased this product should consult their healthcare provider regarding its use.
The recalled product
- Product
- Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407-2); c) 25g (NDC 58597-8407-4); d) 100g (NDC 58597-8407-6), 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
- 7,000
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 (6)
- Lot #: a) 120916-1
- Exp. 10/31/2019
- b) 120916-1
- Exp. 10/31/2019 c) 120916-1
- d) 120916-1
- Exp. 10/31/2019.
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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