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 by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Reported: May 4, 2022 Initiated: April 25, 2022 #D-0793-2022
Product Description
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 by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Reason for Recall
cGMP deviations
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- a) 7,044 bottles; b) 1,014 bottles
- Distribution
- USA nationwide
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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 by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: a) 7,044 bottles; b) 1,014 bottles.
Why was this product recalled? ▼
cGMP deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 4, 2022. Severity: Moderate. Recall number: D-0793-2022.
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