Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
Product description
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
Lot numbers, UPCs & expiration codes
Lot #: 1012275, Exp 02/28/2025
Where it was sold
Nationwide in the USA
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-0320-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 1, 2024
- FDA report date
- Feb 14, 2024
- Quantity
- 2,850 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services LLC
Original FDA data
Every field from FDA enforcement report D-0320-2024, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 93936
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #: 1012275, Exp 02/28/2025
- Postal code
- 43217-1188
- Report date
- Feb 14, 2024
- Product type
- Drugs
- Recall number
- D-0320-2024
- Classification
- Class III
- Recalling firm
- Amerisource Health Services LLC
- Product quantity
- 2,850 cartons
- Termination date
- Sep 1, 2026
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 1, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 8, 2024