Levofloxacin Hemihydrate Recalled for Lack of Stability Data
American Pharmaceutical Ingredients is recalling Levofloxacin Hemihydrate USP for prescription compounding due to missing stability data 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 the product may cause temporary or medically reversible health consequences. The specific hazard is a lack of stability data, which is a quality control issue rather than a direct contamination or acute safety defect.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Levofloxacin Hemihydrate USP for prescription compounding. The product is available in 100g and 1000g packages and is distributed nationwide within the USA. The recall involves Lot 072915-1 with an expiration date of 07/05/2019.
The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the assigned retest or expiration date for the product in its container/closure system.
This recall affects pharmacies and compounding facilities that may have purchased this specific lot of raw ingredient. Consumers should not use this product for compounding. Pharmacies should contact the recalling firm for further instructions on handling the affected inventory.
The recalled product
- Product
- Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), 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
- 10,000
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 (3)
- Lot #: a) 072915-1
- Exp. 07/05/2019
- b) 072915-1
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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