American Pharmaceutical Ingredients Recalls Estrone USP Due to cGMP Deviations
American Pharmaceutical Ingredients LLC is recalling Estrone USP for prescription compounding due to cGMP deviations and lack of quality assurance.
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 could cause temporary or medically reversible health consequences. The source cites cGMP deviations and lack of quality assurance without reporting specific injuries or illnesses, aligning with a moderate severity rating for a voluntary precautionary recall.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Estrone USP, a pharmaceutical ingredient packaged in 1g, 5g, and 25g bottles for prescription compounding. The recall is being conducted due to Current Good Manufacturing Practice (cGMP) deviations and a lack of quality assurance.
The affected product is identified by NDCs 58597-8049-2, 58597-8049-3, and 58597-8049-4. The specific lots involved are 052915-1 and 052915-2, with an expiration date of 5/5/2017. The product was distributed in New York, Georgia, Nevada, California, Kentucky, and Texas.
Consumers and healthcare providers should stop using the affected lots of Estrone USP and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
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 (3)
- Lots: 052915-1
- 052915-2
- exp 5/5/2017
Distribution
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