Reported Jun 1, 2022 · Terminated
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA…
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 Capsules USP, 100 mg, 90-count bottle, Rx Only
- Packaged and Distributed ByDirect Rx Dawsonville, GA 30534
- Manufactured forGlenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
- Lot codes and dates
- Lot23JY2124 Exp. 6/30/23
- Amount recalled
- 16 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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