Drug recall D-1242-2019
Product
Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05
Reason for recall
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Lots and codes
Lot #: Z803518, Exp 08/2020
Recall details
- Recalling firm
- Zydus Pharmaceuticals USA Inc, Pennington, NJ
- Quantity
- 7668 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 22, 2019
- Terminated
- January 14, 2021
Related products
- Carvedilol – drug information
- NDC 68382-092 Carvedilol · Carvedilol 3.125 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-094 Carvedilol · Carvedilol 12.5 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-093 Carvedilol · Carvedilol 6.25 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-095 Carvedilol · Carvedilol 25 mg/1 · Zydus Pharmaceuticals USA Inc.