Carbamazepine ER Tablets Recalled for Potential Label Mixup
Aidapak Services is recalling carbamazepine ER tablets that may be mislabeled as isosorbide dinitrate or sirolimus.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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
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.
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