Class II · Moderate risk
Zonisamide Capsules USP
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Affected NDC
68462-0129-01
Compare with the code on your package — it is the most precise check available.
Drug: Zonisamide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Zonisamide NDC 68462-0129 |
50 mg/1 | Capsule Oral |
Glenmark Pharmaceuticals Inc., USA | Rx |
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- NDC code
- 68462-129-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0825-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Zonisamide recalls
See all
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules USP
cGMP deviations
Class II · Moderate risk
Zonisamide 100 mg Capsules
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Other recalls by Glenmark Pharmaceuticals Inc., USA
All 2021 recalls
Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Class II · Moderate risk
Ondansetron Orally Disintegrating Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
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