Why it was recalled
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Product description
Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
Lot numbers, UPCs & expiration codes
Lot #: 17JU2118 Exp. 5/31/23
Where it was sold
FL only
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0829-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 14, 2021
- FDA report date
- Sep 29, 2021
- Quantity
- 2 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Direct Rx
Original FDA data
Every field from FDA enforcement report D-0829-2021, exactly as published.
Show all FDA fields
- City
- Dawsonville
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 88749
- Address
- 94 Worldwide Dr
- Code information
- Lot #: 17JU2118 Exp. 5/31/23
- Postal code
- 30534-6828
- Report date
- Sep 29, 2021
- Product type
- Drugs
- Recall number
- D-0829-2021
- Classification
- Class II
- Recalling firm
- Direct Rx
- Product quantity
- 2 bottles
- Termination date
- Oct 22, 2021
- Reason for recall
- CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
- Distribution pattern
- FL only
- Recall initiation date
- Sep 14, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 23, 2021