Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0520-2018·Announced 2018-02-28

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Hazard: cgmp-deviation
stability-data
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.

See all 66 products in this recall →

Same manufacturer · American Pharmaceutical Ingredients LLC

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Same hazard · cgmp deviation