FDA Recalls Estrone USP for Prescription Compounding Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Estrone USP for prescription compounding because it lacks stability data and controls 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 the rubric associates with moderate severity when no specific hospitalization reports or high-risk pathogens are present. The hazard is a documentation and stability control issue rather than a confirmed contamination or injury event.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Estrone USP for prescription compounding, packed by American Pharmaceutical Ingredients LLC. The affected product is available in 5 g, 100 mg, and 25 g packages and is distributed nationwide within the United States.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacks the stability data and controls necessary to support the assigned retest or expiration dates for the product in its container/closure system. The affected lots are 052915-2 (expiration 05/05/2017) and 052915-1 (expiration 05/05/2017).
This recall involves a total of 5,000 g of the product. Because the product is for prescription compounding, it is intended for use by licensed pharmacies and healthcare providers rather than direct consumer purchase. Pharmacies and compounding facilities should stop using the affected lots and follow FDA guidance for the return or destruction of the product.
The recalled product
- Product
- Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC 58597-8049-4), 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
- 5,000
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 (5)
- Lot #: a) 052915-2
- Exp. 05/05/2017
- b) 052915-2
- c) 052915-1
- Exp. 05/05/2017.
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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