Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
Reported: November 28, 2012 Initiated: September 27, 2012 #D-059-2013
Product Description
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
Reason for Recall
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 1512 bottles
- Distribution
- Nationwide. No foreign consignees.
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 1512 bottles.
Why was this product recalled? ▼
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 28, 2012. Severity: Moderate. Recall number: D-059-2013.
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