Class II
Terminated
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
- Company
- Direct Rx
- Recall Initiated
- May 13, 2022
- Posted
- June 1, 2022
- Recall Number
- D-0888-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16 bottles
- Firm Location
- Dawsonville, GA, United States
Reason for Recall
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Distribution
Nationwide to the U.S. market
Lot / Code Info
Lot: 23JY2124 Exp. 6/30/23
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