FDA Drug recall D-1230-2015
Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11)
- FDA Drug
- Class II
- terminated
- Published 2015-07-15
On 2015-07-15 the FDA classified a Class II recall of Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11) by American Health Packaging, citing CGMP Deviations: Firm did not adequately investigate customer complaints.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1230-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-01 |
| Published | 2015-07-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | American Health Packaging |
| Distribution | US |
Product
Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Identifiers
| code_info | Lot#: 132383: Exp Date: 07/31/2015; Lot#: 132989 Exp Date: 10/31/2015; Lot#: 133694 Exp Date: 03/31/2016l Lot#: 134418A…Lot#: 132383: Exp Date: 07/31/2015; Lot#: 132989 Exp Date: 10/31/2015; Lot#: 133694 Exp Date: 03/31/2016l Lot#: 134418A Exp Date: 07/31/2016 & Lot#: 134418B Exp Date: 07/31/2016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1230-2015%22
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