CLASS II Drug recall · Reported 29 Sep 2021 · FDA Enforcement Report
Zonisamide, Packaged recalled by Direct Rx
Direct Rx is recalling Zonisamide, Packaged, distributed in Florida. The recall was initiated on 14 Sep 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0829-2021
- FDA event ID
- 88749
- Recalling firm
- Direct Rx, Dawsonville, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Sep 2021
- FDA classified
- 23 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 14 Sep 2021 | Recall initiated by company | |
| 23 Sep 2021 | Classified by FDA | +9 days |
| 29 Sep 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Product as listed by the FDA
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
Where it was distributed
FL only
Questions about this recall
Is Zonisamide, Packaged recalled?
Yes. Direct Rx recalled Zonisamide, Packaged on 14 Sep 2021. The recall is Class II and its status is Terminated. Recall number D-0829-2021.
Why was it recalled?
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Which lots are affected?
Lot #: 17JU2118 Exp. 5/31/23
Where was it sold?
FL only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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