Aidapak Recalls Atorvastatin Calcium Tablets Due to Labeling Error
Aidapak Services, LLC is recalling Atorvastatin Calcium 20 mg tablets because they may be mislabeled as GuaiFENesin ER 600 mg.
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 and involves a labeling mixup, which fits the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling Atorvastatin Calcium Tablet, 20 mg, NDC 60505257909. The recall is due to a labeling mixup where the product may be mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000834.
The affected product is identified by Pedigree W003846 and an expiration date of 6/27/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for the specific NDC and pedigree number listed above. If the product matches the description, they should contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- ATORVASTATIN CALCIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505257909
- 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
- 20 mg has the following code Pedigree: W003846
- EXP: 6/27/2014.
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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