The Recall Desk
ModerateFDA (Drugs)·D-970-2014·Announced 2014-01-29

Aidapak Recalls Nifedipine ER Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling Nifedipine ER 60 mg tablets because they may have been mislabeled as Nicotine Polacrilex 2 mg lozenges.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (label mixup) without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Aidapak Services, LLC is recalling Nifedipine ER, Tablet, 60 mg, NDC 00591319401, due to a labeling error. The recall is classified as Class II by the FDA.

The specific issue is a label mixup where the Nifedipine ER tablets may have been mislabeled as NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001. The affected Nifedipine ER tablets have pedigree W003729 and an expiration date of 6/26/2014. The mislabeled product is identified by pedigree W003749 and the same expiration date.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Consumers and healthcare providers should check their inventory for these specific NDC and pedigree numbers. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions about their medication.

The recalled product

Product
NIFEdipine ER, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591319401.
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)

  • NIFEdipine ER
  • Tablet
  • 60 mg has the following codes: Pedigree: W003729
  • EXP: 6/26/2014.

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

See all →