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.
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 2/5 (Moderate).
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
- 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)
- ATORVASTATIN CALCIUM
- Tablet
- 80 mg has the following code Pedigree: AD21965_4
- EXP: 5/1/2014.
Distribution
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.
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