The Recall Desk
ModerateFDA (Drugs)·D-662-2014·Announced 2014-01-22

Aidapak Recalls Atorvastatin Calcium Tablets Due to Labeling Error

Aidapak Services, LLC is recalling Atorvastatin Calcium 80 mg tablets because they may be mislabeled as Lactobacillus GG capsules.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error, which fits the 'Moderate' criteria for minor labeling errors or low-risk contamination.

Plain-English summary

Aidapak Services, LLC is recalling Atorvastatin Calcium, Tablet, 80 mg, NDC 60505267109. The recall is due to a labeling mixup where the product may be mislabeled as Lactobacillus GG, Capsule, 10 Billion Cells, NDC 49100036374.

The affected product is a prescription-only medication distributed in Arizona, California, Oregon, and Washington. The specific lot identified has the pedigree AD21965_4 and an expiration date of 5/1/2014. The mislabeled product is identified by pedigree AD21965_19 and the same expiration date.

Consumers and healthcare providers should check their inventory for this specific NDC and pedigree. If the product is found, it should be returned to the distributor or the FDA. Patients should consult their healthcare provider for alternative treatment options if they have received this product.

The recalled product

Product
ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505267109
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)

  • ATORVASTATIN CALCIUM
  • Tablet
  • 80 mg has the following code Pedigree: AD21965_4
  • EXP: 5/1/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 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 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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