Reported Nov 20, 2024 · Terminated
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 341 Mason Rd · La Vergne, TN · 37086-3606
Is this the product you have?
- Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton
- Distributed byAvet Pharmaceuticals Inc., East Brunswick, NJ 08816
- Distributed byMAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61
- Lot codes and dates
Lot#: T04888Exp 11/2024T04946Exp 12/2024T04970Exp 07/2025
- Amount recalled
- 25814 tablets
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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