Class II
Terminated
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.
- Company
- Ascend Laboratories, Llc
- Recall Initiated
- January 24, 2020
- Posted
- February 12, 2020
- Recall Number
- D-0828-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 192 Bottles
- Firm Location
- Parsippany, NJ, United States
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.
Distribution
Nationwide in the U.S.
Lot / Code Info
Lot #: 19122552, Exp 7/31/2021
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