FDA Recalls Valsartan Tablets Due to Potential Labeling Mixup
Aidapak Services, LLC is recalling Valsartan 80 mg tablets because they may have been mislabeled as other prescription drugs.
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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when there is a risk of significant injury or property damage, such as administering the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling Valsartan, Tablet, 80 mg, NDC 00078035834, due to a labeling mixup. The recalled product may have been mislabeled as Temazepam, Capsule, 7.5 mg; Valsartan, Tablet, 320 mg; Isosorbide Mononitrate, Tablet, 20 mg; or Cholecalciferol, Tablet.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves specific pedigree codes and expiration dates ranging from May 17, 2014, to June 21, 2014. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers should check their medication labels against the specific pedigree codes and expiration dates listed in the official recall notice. If the medication matches the recalled product, it should be returned to the pharmacy or contact the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- VALSARTAN, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078035834.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 1,440
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 (18)
- VALSARTAN
- Tablet
- 80 mg has the following codes: Pedigree: AD52372_4
- EXP: 5/17/2014
- Pedigree: AD65475_10
- EXP: 5/28/2014
- Pedigree: AD68025_1
- Pedigree: AD70585_1
- EXP: 5/29/2014
- Pedigree: W002768
- EXP: 6/10/2014
- Pedigree: W003535
- EXP: 6/21/2014
- Pedigree: AD62995_4
- Pedigree: AD73597_1
- EXP: 5/31/2014
- Pedigree: W002616
- EXP: 6/4/2014.
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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