American Pharmaceutical Ingredients Recalls Stanozolol USP Due to CGMP Deviations
American Pharmaceutical Ingredients LLC is recalling Stanozolol USP for prescription compounding due to lack of stability data and controls supporting 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 indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The hazard is a documentation and stability control issue rather than a confirmed contamination or injury event.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Stanozolol USP for prescription compounding. The product is available in 25g, 100g, 500g, and 1000g packages and is intended for prescription use only. The recall involves a total quantity of 12,300 g distributed nationwide within the USA.
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.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions. The affected lot number is 080616-1, with a date of 4/26/2019.
The recalled product
- Product
- Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7); d)1000g (NDC 58597-8525-8), 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
- 12,300
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 (6)
- Lot #: a) 080616-1
- 4/26/2019
- b) 080616-1
- c) 080616-1
- d) 080616-1
- 4/26/2019.
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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