Fluticasone Propionate USP Recalled for Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Fluticasone propionate USP for prescription compounding due to a lack of stability data and controls to support 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, a violative product may cause temporary or medically reversible adverse health consequences. The specific hazard is a documentation and stability control issue rather than a direct contamination or acute injury risk.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Fluticasone propionate USP (Micronized) for prescription compounding. The product is available in 1g, 10g, 25g, and 100g packages and is distributed nationwide within the USA. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically a lack of stability data and controls to support the manufacturers assigned retest or expiration date in the firm's container/closure system.
This recall affects specific lots of the product with expiration dates ranging from April 30, 2020, to December 31, 2020. The affected lot numbers include 052615-2, 020916-1, 092115-1, 092115-2, 110315-3, and 110315-2. The product is intended for prescription use only.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the supplier or disposed of according to local regulations. No specific instructions for patient management are provided in the source text.
The recalled product
- Product
- Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
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 (12)
- Lot #: a) 052615-2
- Exp. 4/30/2020
- 020916-1
- Exp. 12/31/2020
- b) 092115-1
- Exp. 8/31/2020
- 092115-2
- 110315-3
- Exp. 9/30/2020
- c) 020916-1
- 110315-2
- d) 020916-1
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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