Valsartan Tablets Recalled for Potential Labeling Mixup with Other Drugs
Aidapak Services is recalling Valsartan 160 mg tablets because they may have been mislabeled as other medications. The repacked drugs were distributed in four western states.
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 2/5 (Moderate).
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 mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity category.
Plain-English summary
Aidapak Services, LLC is recalling Valsartan, Tablet, 160 mg (NDC 00078035934) due to a labeling error. The source text indicates that the Valsartan tablets may have potentially been mislabeled as one of three other specific drugs: Progesterone, Capsule, 100 mg; CapsuleTOPRIL, Tablet, 6.25 mg; or Mycophenolate Mofetil, Tablet, 500 mg.
The recalled product consists of 1,260 tablets. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The source text lists specific pedigree codes and expiration dates for the affected Valsartan lots, ranging from May 16, 2014, to June 25, 2014.
Consumers and healthcare providers should check their inventory for Valsartan 160 mg tablets with the specific pedigree codes listed in the recall notice. If the product matches the description, it should be stopped from use and returned to the distributor or pharmacy for proper handling.
The recalled product
- Product
- VALSARTAN, Tablet, 160 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078035934.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,260
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 (19)
- VALSARTAN
- Tablet
- 160 mg has the following codes: Pedigree: AD39858_1
- EXP: 5/16/2014
- Pedigree: AD46312_7
- Pedigree: AD49414_7
- EXP: 5/17/2014
- Pedigree: W002767
- EXP: 6/6/2014
- Pedigree: W003534
- EXP: 6/21/2014
- Pedigree: W003639
- EXP: 6/25/2014
- Pedigree: W002851
- EXP: 6/7/2014
- Pedigree: AD62995_1
- EXP: 5/28/2014
- Pedigree: W002964
- EXP: 6/11/2014.
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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