Reported Sep 29, 2021 · Terminated
Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For…
Direct Rx
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Direct Rx · 94 Worldwide Dr · Dawsonville, GA · 30534-6828
Is this the product you have?
Zonisamide 100 mg Capsules30-count bottles
- Packaged and Distributed ByDirect Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
- Lot codes and dates
- Lot #: 17JU2118 Exp. 5/31/23
- Amount recalled
- 2 bottles
Where it was sold
Why it was recalled
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
This product could cause temporary or reversible health problems — stop using it.
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