The Recall Desk
SevereFDA (Drugs)·D-827-2014·Announced 2014-01-29

Aidapak Recalls Nortriptyline Capsules Due to Potential Label Mixup

Aidapak Services, LLC is recalling 10 mg Nortriptyline HCL capsules because they may have been mislabeled as 80 mg Valsartan 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 corresponds to a Severe severity score (4) under the rubric, as it involves a potential mislabeling of prescription drugs that could lead to adverse health consequences.

Plain-English summary

Aidapak Services, LLC is recalling 100-count bottles of 10 mg Nortriptyline HCL capsules (NDC 00093081001) due to a labeling error. The recall was initiated because the capsules may have been mislabeled as 80 mg Valsartan tablets (NDC 00078035834). Both products share the same pedigree code (AD70585) and expiration date (May 29, 2014).

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

Consumers who have this product should contact their healthcare provider or pharmacist for guidance. They should not take the medication if they are unsure of the correct label or dosage.

The recalled product

Product
NORTRIPTYLINE HCL, Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093081001.
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)

  • NORTRIPTYLINE HCL
  • Capsule
  • 10 mg has the following codes: Pedigree: AD70585_4
  • EXP: 5/29/2014.

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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