The Recall Desk
SevereFDA (Drugs)·D-975-2014·Announced 2014-01-29

FDA Recalls Mislabeled Quinidine Sulfate Tablets Distributed by Aidapak

Aidapak Services, LLC is recalling Quinidine Sulfate 200 mg tablets that may have been mislabeled as Quinapril 40 mg. The error occurred during repacking in four western states.

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 corresponds to a Severe severity score under the rubric. The hazard involves a significant labeling error that could lead to the administration of the wrong medication.

Plain-English summary

The U.S. Food and Drug Administration has issued a recall for Quinidine Sulfate, Tablet, 200 mg, distributed by Aidapak Services, LLC. The recall is due to a labeling mixup where the medication may have been incorrectly labeled as Quinapril, Tablet, 40 mg.

The affected product is identified by NDC 00591543801, with a pedigree of AD52778_79 and an expiration date of 5/21/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The mislabeled product is associated with NDC 31722027090 and pedigree AD52778_76.

Consumers and healthcare providers should check their inventory for the specific Quinidine Sulfate tablets described above. If the product is found, it should be returned to the distributor or a local pharmacy for proper disposal. Patients should consult their healthcare provider if they have questions regarding their medication.

The recalled product

Product
quiNIDine SULFATE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591543801.
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)

  • quiNIDine SULFATE
  • Tablet
  • 200 mg has the following codes: Pedigree: AD52778_79
  • EXP: 5/21/2014.

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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