American Pharmaceutical Ingredients Recalls Anastrozole USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Anastrozole USP for prescription compounding because the manufacturer lacked stability data and controls 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 corresponds to a moderate severity score. The hazard involves a lack of stability data, which is a quality control issue rather than a direct, reported physical injury or high-risk pathogen contamination.
Plain-English summary
American Pharmaceutical Ingredients LLC is voluntarily recalling Anastrozole USP for prescription compounding. The affected product is packaged in 1g, 5g, and 25g containers and is intended for prescription use only. The recall involves a total of 684 grams of the product.
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 lots are identified as 011116-1 and 011116-2, with an expiration date of 07/31/2020.
The product was distributed nationwide within the United States. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 684
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) 011116-1
- Exp. 07/31/2020
- b) 011116-1
- 011116-2
- c) 011116-1
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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