Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1230-2015·Announced 2015-07-15

Zonisamide capsules recalled for inadequate complaint investigation

American Health Packaging is recalling Zonisamide capsules due to current good manufacturing practice deviations involving inadequate investigation of customer complaints.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The specific deviation is procedural (inadequate complaint investigation) rather than a direct physical hazard like contamination or mislabeling, fitting the Moderate severity criteria for voluntary precautionary or process-related recalls.

Plain-English summary

American Health Packaging is recalling Zonisamide capsules, USP 100mg, packaged in 10-count blisters. The product is distributed nationwide and is available by prescription only. The recall involves 5,416 cartons.

The recall was initiated due to current good manufacturing practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The affected lots include 132383, 132989, 133694, 134418A, and 134418B, with expiration dates ranging from July 31, 2015, to July 31, 2016.

Consumers with this product should contact their healthcare provider or pharmacist for guidance on disposal or replacement. The product is manufactured by Wockhardt Limited, Mumbai, India, and distributed by Wockhardt, USA, LLC.

The recalled product

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…
Manufacturer: American Health Packaging
Category: Drug — Anticonvulsant
Hazard: cgmp-deviation
process-error
Affected units: 5,416

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot#: 132383: Exp Date: 07/31/2015
Lot#: 132989 Exp Date: 10/31/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by American Health Packaging under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Same manufacturer · American Health Packaging

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