Simvastatin Tablets Recalled for Potential Labeling Error
Aidapak Services is recalling Simvastatin 5 mg tablets that may be mislabeled as Losartan Potassium 25 mg.
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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Aidapak Services, LLC is recalling Simvastatin, Tablet, 5 mg (NDC 00093715298) due to a potential labeling error. The recalled product may have been mislabeled as Losartan Potassium, Tablet, 25 mg (NDC 13668011390). The specific pedigree for the recalled Simvastatin is AD65323_13 with an expiration date of 5/29/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as FDA Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for Simvastatin 5 mg tablets with pedigree AD65323_13 and expiration date 5/29/2014. If found, these products should be quarantined and returned to the distributor or manufacturer for credit.
The recalled product
- Product
- SIMVASTATIN, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093715298.
- 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 (4)
- SIMVASTATIN
- Tablet
- 5 mg has the following codes: Pedigree: AD65323_13
- EXP: 5/29/2014.
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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