Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0319-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 15, 2024
- FDA report date
- Feb 14, 2024
- Quantity
- 858 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
Original FDA data
Every field from FDA enforcement report D-0319-2024, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 93813
- Address
- 50 Horseblock Rd
- Code information
- Lot # AM221153, Exp. date 06/30/2024; AM230497, Exp. date 02/29/2025
- Postal code
- 11719-9509
- Report date
- Feb 14, 2024
- Product type
- Drugs
- Recall number
- D-0319-2024
- Classification
- Class II
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Product quantity
- 858 bottles
- Termination date
- Jan 31, 2025
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Jan 15, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2024