Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.
Reported: February 12, 2020 Initiated: January 24, 2020 #D-0828-2020
Product Description
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.
Reason for Recall
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Details
- Recalling Firm
- Ascend Laboratories LLC
- Units Affected
- 192 Bottles
- Distribution
- Nationwide in the U.S.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.. Recalled by Ascend Laboratories LLC. Units affected: 192 Bottles.
Why was this product recalled? ▼
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 12, 2020. Severity: Moderate. Recall number: D-0828-2020.
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