Phentolamine Mesylate Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Phentolamine Mesylate 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 involves a reasonable probability of temporary or medically reversible health consequences. The hazard is a documentation and stability data issue rather than a direct contamination or acute injury risk, fitting the Moderate severity criteria for minor labeling or documentation errors.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Phentolamine Mesylate USP for prescription compounding. The product is available in 1g, 5g, and 500g packages and is distributed nationwide in the United States. The specific lot number is 080315-1, with an expiration date of 04/05/2018.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the assigned retest or expiration dates for the product in its current container/closure system.
This recall affects pharmacies and compounding facilities that may have received or used this specific lot of Phentolamine Mesylate USP. Consumers should not use the recalled product and should contact their pharmacist or healthcare provider for guidance on alternative treatments or replacements.
The recalled product
- Product
- Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), 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
- 6,000
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 (5)
- Lot #: a) 080315-1
- Exp. 04/05/2018
- b) 080315-1
- c) 080315-1
- Exp. 04/05/2018.
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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