Reported May 4, 2022 · Completed
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC…
Glenmark Pharmaceuticals Inc., USA
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: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
- Zonisamide Capsules, USP, 100 mg
- packaged in
a) 100-count bottle (NDC 68462-130-01)b) 500-count bottle (NDC 68462-130-05)Rx only
- Manufactured byGlenmark Pharmaceuticals, Inc., USA Monroe, NC 28110
- Manufactured forGlenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
- Lot codes and dates
a) Lot #: 29200053Exp 4/30/2023b) Lot #: 29200054Exp 4/30/2023
- Amount recalled
- a) 7,044 bottles; b) 1,014 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
cGMP deviations
This product could cause temporary or reversible health problems — stop using it.
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