The Recall Desk
SevereFDA (Drugs)·D-689-2014·Announced 2014-01-22

Aidapak Recalls Mislabeled Pantoprazole Sodium Tablets

Aidapak Services, LLC is recalling 20 mg Pantoprazole Sodium tablets that may be mislabeled as Fosinopril Sodium. The error involves a label mixup on repacked drugs.

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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as taking the wrong medication) are scored as 4 (Severe), as they are not Class I but involve significant risk.

Plain-English summary

Aidapak Services, LLC is recalling 90-count bottles of Pantoprazole Sodium DR Tablets, 20 mg, NDC 64679043304. The recall is due to a labeling error where the product may be mislabeled as Fosinopril Sodium, Tablet, 20 mg, NDC 60505251102. The affected product has the pedigree AD70690_4 and an expiration date of 5/29/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for instructions on how to return the medication or obtain a replacement. Do not take the medication if the label does not match the prescription provided.

The recalled product

Product
PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043304
Affected units
90

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)

  • PANTOPRAZOLE SODIUM DR Tablet
  • 20 mg has the following codes Pedigree: AD70690_4
  • EXP: 5/29/2014.

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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