The Recall Desk
SevereFDA (Drugs)·D-856-2014·Announced 2014-01-29

FDA Recalls Mislabeled Mexiletine HCL Capsules Distributed by Aidapak Services

Aidapak Services, LLC is recalling 200 mg Mexiletine HCL capsules that may have been mislabeled as 10 mg Isosorbide Dinitrate tablets.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which involves a potential for temporary or medically reversible adverse health consequences. Per the rubric, FDA Class II recalls with significant injury potential or hospitalization reports are rated Severe (4).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for MEXILETINE HCL, Capsule, 200 mg, distributed by Aidapak Services, LLC. The recall is due to a labeling error where the product may have been mislabeled as ISOSORBIDE DINITRATE, Tablet, 10 mg.

The affected product is identified by NDC 00093874001, Pedigree AD25264_7, and an expiration date of 5/3/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The mislabeled product is identified by NDC 00781155601, Pedigree AD25264_1, and an expiration date of 5/3/2014.

Consumers and healthcare providers should check their inventory for these specific codes and stop using the product if it matches the description. They should contact their pharmacist or the recalling firm for further instructions on how to return or dispose of the medication.

The recalled product

Product
MEXILETINE HCL, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093874001.
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 (4)

  • MEXILETINE HCL
  • Capsule
  • 200 mg has the following codes: Pedigree: AD25264_7
  • EXP: 5/3/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 265 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 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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