The Recall Desk
SevereFDA (Drugs)·D-841-2014·Announced 2014-01-29

Simvastatin Tablets Recalled for Potential Labeling Error

Aidapak Services is recalling Simvastatin 5 mg tablets that may be mislabeled as Losartan Potassium 25 mg.

What this means for you

Illness, injury, or structural failure has been reported. 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.
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

Distributed in 4 states:

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.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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