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
Reported: October 11, 2023 Initiated: September 1, 2023 #D-0039-2024
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
Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Details
- Recalling Firm
- Amerisource Health Services LLC
- Units Affected
- 3,344 cartons
- Distribution
- Nationwide in the USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amerisource Health Services LLC. Units affected: 3,344 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 11, 2023. Severity: Low. Recall number: D-0039-2024.
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