FDA Recalls Diclofenac Sodium USP Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Diclofenac Sodium USP for prescription compounding because it lacks stability data 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 involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a lack of stability data, which is a quality control issue rather than a confirmed contamination or acute injury risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Diclofenac Sodium USP for prescription compounding, packed by American Pharmaceutical Ingredients LLC. The product is available in 25g, 100g, 500g, and 1000g packages and is distributed nationwide within the United States.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacks the stability data and controls necessary to support the assigned retest or expiration dates for the product in its current container/closure system.
This recall affects healthcare professionals and pharmacies that may have purchased or compounded this ingredient. Consumers should not use the product and should contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g (NDC 58597-8012-7); d) 1000g (NDC 58597-8012-8), 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
- 116,850
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 (10)
- Lot #: a) 082715-1
- Exp. 06/24/2018
- 061715-1
- Exp. 6/6/2018
- 072516-2
- Exp. 07/04/2019
- b) 082715-1
- c) 061715-1
- 082715-1
- d) 072516-1
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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