American Pharmaceutical Ingredients Recalls Medroxyprogesterone Acetate Due to Stability Data Gaps
American Pharmaceutical Ingredients is recalling 12,000 grams of Medroxyprogesterone Acetate USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration date.
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 corresponds to a moderate severity score of 2, especially given the nature of the defect is a documentation/stability data gap rather than a confirmed contamination or acute hazard.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling 12,000 grams of Medroxyprogesterone Acetate USP (Micronized) for prescription compounding. The product is packed in 1,000 g containers and is distributed nationwide within the United States. The specific lot affected is 081415-2, with an expiration date of 05/03/2018.
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 retest or expiration date assigned to the product in its container/closure system. This deficiency means the product's stability over time has not been adequately verified.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for instructions on return or disposal. This recall is classified as Class II by the FDA, indicating a reasonable probability that temporary or medically reversible health consequences may occur.
The recalled product
- Product
- Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Water ford, MI 48327, NDC 58597-8055-8
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 12,000
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 (2)
- Lot #: 081415-2
- Exp. 05/03/2018
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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