Recalls / Class III
Class IIID-0039-2024
Product
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
- Affected lot / code info
- Lot#: 1007002, Exp 12/31/2023
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 3,344 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-09-01
- FDA classified
- 2023-10-05
- Posted by FDA
- 2023-10-11
- Terminated
- 2024-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0039-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.