FDA Recalls Famciclovir Tablets Due to Potential Label Mixup
Aidapak Services is recalling Famciclovir 500 mg tablets because they may have been mislabeled as Tolterodine or Thiamine.
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, which corresponds to a moderate severity score under the rubric for minor labeling errors or low-risk contamination without reported serious injuries.
Plain-English summary
Aidapak Services, LLC is recalling Famciclovir 500 mg tablets (NDC 00093811956) due to a potential label mixup. The recalled product consists of 60-tablet bottles distributed by AidaPak Service, LLC.
The recall was initiated because the Famciclovir tablets may have been mislabeled as Tolterodine Tartrate ER 4 mg capsules or Thiamine HCL 100 mg tablets. The affected Famciclovir lots have pedigree codes AD49448_4 (expiration 5/17/2014) and AD54549_4 (expiration 5/20/2014). The potentially mislabeled products include Tolterodine Tartrate ER (Pedigree AD49448_1) and Thiamine HCL (Pedigree AD54559_1).
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Patients and healthcare providers should verify the labels on their medication bottles and contact their pharmacist or physician if they have questions regarding the specific lot numbers or expiration dates involved in this recall.
The recalled product
- Product
- FAMCICLOVIR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093811956.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 60
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)
- FAMCICLOVIR
- Tablet
- 500 mg has the following codes: Pedigree: AD49448_4
- EXP 5/17/2014
- Pedigree: AD54549_4
- EXP: 5/20/2014.
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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