Recalls / Class II
Class IID-1041-2017
Product
Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01
- Affected lot / code info
- MR6317 Exp.05/17 MR6318 Exp. 05/17 MR6319 Exp. 05/17 MR5361 Exp. 06/17 MR9007 Exp. 08/17 MR10000 Exp. 08/17 MR10923 Exp. 10/17 MR10924 Exp. 10/17 MR10925 Exp. 10/17 MR11554 Exp. 11/17 MR11555 Exp. 11/17 MS1359 Exp. 12/17
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- 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
- 108,096 HDPE bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-05-10
- FDA classified
- 2017-07-31
- Posted by FDA
- 2017-08-09
- Terminated
- 2020-01-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1041-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.