The Recall Desk
SevereFDA (Drugs)·D-510-2014·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 nortriptyline hydrochloride capsules.

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, and the rubric specifies that FDA Class II recalls with potential for adverse health consequences are rated as Severe (4).

Plain-English summary

Aidapak Services, LLC is recalling 90-count bottles of 20 mg pantoprazole sodium tablets (NDC 13668009690) due to a labeling error. The product, identified by pedigree W003695 and expiration date 6/26/2014, may be mislabeled as 75 mg nortriptyline hydrochloride capsules (NDC 00093081301, pedigree W003694).

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

Consumers should check their medication for the specific NDC and pedigree numbers listed above. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance on appropriate alternatives.

The recalled product

Product
PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668009690
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 (4)

  • PANTOPRAZOLE SODIUM DR
  • Tablet
  • 20 mg has the following code Pedigree: W003695
  • EXP: 6/26/2014.

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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