HydrALAZINE Hydrochloride Tablets recall: Impurity Out of Spec
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
Why was HydrALAZINE Hydrochloride Tablets recalled?
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
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#: 1007002, Exp 12/31/2023
- 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
- Recalling firm
- Amerisource Health Services LLC
- Quantity
- 3,344 cartons
- Distribution
- Nationwide in the USA
- Recall date
- October 11, 2023
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)