Recalls / Class II
Class IID-1135-2015
Product
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
- Brand name
- Divalproex Sodium
- Generic name
- Divalproex Sodium
- Active ingredient
- Divalproex Sodium
- Route
- Oral
- NDC
- 55111-533
- FDA application
- ANDA090161
- Affected lot / code info
- 100 count bottle - Lot #C307859, exp 09/2015; 500 count bottle - Lot #C307859 and Lot# C307812, exp 09/2015
Why it was recalled
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 100 count 7479; 500 count - 2544
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-05-22
- FDA classified
- 2015-06-12
- Posted by FDA
- 2015-06-24
- Terminated
- 2017-04-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1135-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.