Recalls / Class II
Class IID-1273-2019
Product
Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05
- 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
- Z804517, exp Nov 30, 2020
Why it was recalled
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
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
- 3900
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-04-25
- FDA classified
- 2019-05-07
- Posted by FDA
- 2019-05-15
- Terminated
- 2021-06-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1273-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.