Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Product description
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11
Lot numbers, UPCs & expiration codes
Lot#: 1007002, Exp 12/31/2023
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-0039-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 1, 2023
- FDA report date
- Oct 11, 2023
- Quantity
- 3,344 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services LLC
Original FDA data
Every field from FDA enforcement report D-0039-2024, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 93089
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot#: 1007002, Exp 12/31/2023
- Postal code
- 43217-1188
- Report date
- Oct 11, 2023
- Product type
- Drugs
- Recall number
- D-0039-2024
- Classification
- Class III
- Recalling firm
- Amerisource Health Services LLC
- Product quantity
- 3,344 cartons
- Termination date
- Jul 16, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 1, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 5, 2023