The Recall Desk
SevereFDA (Drugs)·D-820-2014·Announced 2014-01-29

Carbamazepine ER Tablets Recalled for Potential Label Mixup

Aidapak Services is recalling carbamazepine ER tablets that may be mislabeled as isosorbide dinitrate or sirolimus.

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 rating under the rubric, particularly given the risk of administering incorrect medications.

Plain-English summary

Aidapak Services, LLC is recalling carbamazepine ER, 100 mg tablets (NDC 00078051005) due to a potential label mixup. The recalled product may have been mislabeled as either isosorbide dinitrate ER, 40 mg tablets or sirolimus, 1 mg tablets.

The affected carbamazepine ER tablets have the following pedigree and expiration codes: Pedigree AD30140_22 with an expiration date of 5/7/2014, or Pedigree W003330 with an expiration date of 6/18/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their medication labels and contact their pharmacist or physician if they have the affected product. Do not use the medication if the label does not match the prescription.

The recalled product

Product
carBAMazepine ER, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078051005.
Affected units
200

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 (6)

  • carBAMazepine ER
  • Tablet
  • 100 mg has the following codes: Pedigree: AD30140_22
  • EXP: 5/7/2014
  • Pedigree:W003330
  • EXP: 6/18/2014.

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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