hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
Reported: March 23, 2022 Initiated: February 24, 2022 #D-0653-2022
Product Description
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Details
- Recalling Firm
- The Harvard Drug Group
- Units Affected
- 5,953 cartons
- Distribution
- Nationwide within USA
- Location
- Livonia, MI
Frequently Asked Questions
What product was recalled? ▼
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61. Recalled by The Harvard Drug Group. Units affected: 5,953 cartons.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 23, 2022. Severity: Moderate. Recall number: D-0653-2022.
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