Recalls / Class II
Class IID-0754-2021
Product
Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01
- Affected lot / code info
- Lot # B1273286-071521, Exp 07/31/2022
Why it was recalled
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 4
- Distribution pattern
- Product was distributed to two medical facilities in VA and FL.
Timeline
- Recall initiated
- 2021-08-17
- FDA classified
- 2021-08-20
- Posted by FDA
- 2021-09-01
- Terminated
- 2022-03-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0754-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.