The Recall Desk
ModerateFDA (Drugs)·D-693-2014·Announced 2014-01-22

Zonisamide Capsules Recalled Due to Potential Labeling Mixup

Aidapak Services is recalling Zonisamide capsules that may be mislabeled as Phytonadione tablets due to a labeling error.

What this means for you

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 and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling Zonisamide Capsule, 100 mg, NDC 64679099001, due to a labeling mixup. The product may be potentially mislabeled as PHYTONADIONE, Tablet, 5 mg, NDC 25010040515.

The recalled Zonisamide capsules have the pedigree W003786 and an expiration date of 6/27/2014. The potentially mislabeled Phytonadione tablets have the pedigree W003737 and an expiration date of 5/31/2014.

Repacked drugs were distributed in Arizona, California, Oregon, and Washington. Consumers should check their medication for the specific NDC and pedigree numbers listed above and contact their pharmacist or healthcare provider if they have questions.

The recalled product

Product
ZONISAMIDE Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679099001
Affected units
100

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 (3)

  • ZONISAMIDE Capsule
  • 100 mg has the following code Pedigree: W003786
  • EXP: 6/27/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 recalled by Aidapak Services, LLC 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 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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