hydrALAZINE HCl Tablets recall: Impurity Out of Spec
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
Why was hydrALAZINE HCl Tablets recalled?
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: T03755, T03756, Exp. Date 03/2023
- Product
- 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
- Recalling firm
- The Harvard Drug Group
- Quantity
- 5,953 cartons
- Distribution
- Nationwide within USA
- Recall date
- March 23, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)