Divalproex Sodium Delayed-Release Tablets recall: Failed Dissolution
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
Why was Divalproex Sodium Delayed-Release Tablets recalled?
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: HAC1312A, EXP. 05/2024
- Product
- Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 9552 bottles
- Distribution
- Nationwide in the USA
- Recall date
- August 3, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)