The Recall Desk
SevereFDA (Drugs)·D-879-2014·Announced 2014-01-29

Aidapak Recalls Lovastatin Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling 20 mg Lovastatin tablets because they may have been mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of patients receiving incorrect prescription medications.

Plain-English summary

Aidapak Services, LLC is recalling 300-tablet bottles of Lovastatin, 20 mg tablets, distributed under NDC 00185007201. The recall is due to a labeling error where the product may have been mislabeled as Aspirin EC DR 81 mg, Fluvastatin Sodium 20 mg, or Dutasteride 0.5 mg. The affected lots have pedigree codes AD28369_1, AD73597_10, and W003263, with expiration dates ranging from May 7, 2014, to June 17, 2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, indicating a situation that might cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected Lovastatin tablets and contact their pharmacist or healthcare provider for a replacement. Patients should not switch to the potentially mislabeled drugs without medical guidance, as the incorrect medications may not be appropriate for their condition.

The recalled product

Product
LOVASTATIN, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00185007201.
Affected units
300

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 (8)

  • LOVASTATIN
  • Tablet
  • 20 mg has the following codes: Pedigree: AD28369_1
  • EXP: 5/7/2014
  • Pedigree: AD73597_10
  • EXP: 5/31/2014
  • Pedigree: W003263
  • EXP: 6/17/2014.

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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