Amneal Phenoxybenzamine Hydrochloride Capsules 10mg Recalled Due to Unknown Impurity
Amneal Pharmaceuticals is recalling Phenoxybenzamine Hydrochloride Capsules, 10mg, due to an unknown impurity. The recall affects 858 bottles distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification indicates a serious adverse health consequence is possible. The source does not report any illnesses or injuries. The hazard is an unknown impurity failing product specifications.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling Phenoxybenzamine Hydrochloride Capsules, USP 10mg in 100-count bottles. The recall involves 858 bottles distributed nationwide. The product is manufactured by Amneal Pharmaceuticals Pvt. Ltd in Ahmedabad, India and distributed by Amneal Pharmaceuticals LLC in Bridgewater, New Jersey.
The recall was initiated because the product failed impurities and degradation specifications due to the presence of an unknown impurity. The FDA classified this as a Class II recall.
The affected lot numbers are AM221153 (expiration 06/30/2024) and AM230497 (expiration 02/29/2025). Patients with affected bottles should contact their healthcare provider or pharmacist for guidance regarding their treatment and next steps.
Consumers who have this medication should check their bottles to determine if they contain one of the affected lots. Questions may be directed to the healthcare provider, pharmacist, or the FDA.
The recalled product
- Product
- Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Hazard
- unknown-impurity
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 (4)
- Lot # AM221153
- Exp. date 06/30/2024
- AM230497
- Exp. date 02/29/2025
Distribution
Distributed nationwide across the United States.
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