FDA Recalls Estriol USP for Prescription Compounding Due to Stability Data Issues
American Pharmaceutical Ingredients LLC is recalling Estriol USP (Micronized) (Yam) for prescription compounding due to a lack of stability data and controls 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 involves a situation that may cause temporary or medically reversible adverse health consequences. The hazard is a documentation and stability data issue rather than a direct contamination or acute injury risk, fitting the Moderate severity criteria for minor labeling or documentation errors.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling specific lots of Estriol USP (Micronized) (Yam) for prescription compounding. The product is available in 5g, 25g, and 100g packages and is distributed nationwide within the USA. The recall involves a total of 3,675 g of the product.
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 is an FDA Class II recall.
Healthcare providers and pharmacies should stop using the affected lots and contact the recalling firm for instructions on return or disposal. Patients who have already used the product should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c) 100g (NDC 58597-8048-6), 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
- 3,675
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 (10)
- Lot #: a) 111516-1
- Exp. 9/19/2018
- 011817-1
- Exp. 9/10/2018
- 111616-1
- Exp. 5/18/2018
- 052317A-1
- Exp. 5/27/2019
- b) 011817-1
- c) 011817-1
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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