The Recall Desk
SevereFDA (Drugs)·D-900-2014·Announced 2014-01-29

Aidapak Recalls Atorvastatin Calcium Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling Atorvastatin Calcium 10 mg tablets because they may have been mislabeled as other prescription drugs.

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 agency classifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as receiving the wrong medication) are classified as Severe (Score 4), as they are more serious than Class III but do not meet the criteria for Critical (Class I) or known fatalities.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling Atorvastatin Calcium, Tablet, 10 mg (NDC 00378201577) due to a labeling error. The agency classifies this as a Class II recall, indicating a situation that may cause temporary or medically reversible adverse health consequences.

The recall is necessary because the Atorvastatin Calcium tablets may have been mislabeled as other prescription medications, including Pancrelipase DR, Omeprazole/Sodium Bicarbonate, and Aspirin Chew. This mixup could lead to patients receiving the wrong medication.

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates are listed in the official recall notice. Patients and healthcare providers should check their medication labels and contact their pharmacist or physician if they have questions about the products listed in the recall.

The recalled product

Product
ATORVASTATIN CALCIUM, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378201577.
Affected units
990

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 (10)

  • ATORVASTATIN CALCIUM
  • Tablet
  • 10 mg has the following codes: Pedigree: AD33897_4
  • EXP: 5/9/2014
  • Pedigree: AD49582_7
  • EXP: 5/16/2014
  • Pedigree: W002774
  • EXP: 6/6/2014
  • Pedigree: W003095
  • EXP: 6/12/2014

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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