Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
Reported: August 25, 2021 Initiated: August 13, 2021 #D-0753-2021
Product Description
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
Reason for Recall
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- 2880 bottles
- Distribution
- Nationwide in the US
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05. Recalled by Zydus Pharmaceuticals (USA) Inc. Units affected: 2880 bottles.
Why was this product recalled? ▼
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 25, 2021. Severity: Moderate. Recall number: D-0753-2021.
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