Recalls / Class III
Class IIID-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
- Brand name
- Carvedilol
- Generic name
- Carvedilol
- Active ingredient
- Carvedilol
- Route
- Oral
- NDCs
- 68382-092, 68382-093, 68382-094, 68382-095
- FDA application
- ANDA077614
- Affected lot / code info
- Lot #: Z803518, Exp 08/2020
Why it was recalled
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.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 7668 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-04-22
- FDA classified
- 2019-04-25
- Posted by FDA
- 2019-05-01
- Terminated
- 2021-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1242-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.