Entecavir Tablets Recalled Due to Potential Label Mixup
Aidapak Services is recalling Entecavir tablets because they may be mislabeled as other prescription drugs.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential label mixup for prescription drugs, which poses a risk of harm if the wrong medication is administered, but no injuries or illnesses have been reported.
Plain-English summary
Aidapak Services, LLC is recalling Entecavir 0.5 mg tablets (NDC 00003161112) due to a labeling error. The recalled medication may be potentially mislabeled as Aripiprazole 2 mg, Amiloride HCl 5 mg, or Atomoxetine HCl 80 mg.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates for the affected lots are listed in the agency's recall notice.
Consumers should check their medication labels and contact their pharmacist or healthcare provider if they have the affected product. Do not take the medication if the label does not match the prescription.
The recalled product
- Product
- ENTECAVIR, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00003161112.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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 (7)
- ENTECAVIR
- Tablet
- 0.5 mg has the following codes: Pedigree: AD30140_28
- EXP: 5/7/2014
- Pedigree: W003687
- EXP: 6/26/2014
- Pedigree: AD60272_58. EXP: 5/22/2014.
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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