Aidapak Recalls Atorvastatin Calcium Tablets Due to Labeling Error
Aidapak Services is recalling 811 tablets of 20 mg Atorvastatin Calcium because they may be mislabeled as other drugs.
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 error (mislabeling) without reported injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling 811 tablets of Atorvastatin Calcium, 20 mg, NDC 00378201777. The recall is due to a labeling error where the product may have been mislabeled as Coenzyme Q-10, 100 mg, or Atorvastatin Calcium, 10 mg.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific pedigree codes and expiration dates for the recalled product are AD33897_7 (EXP: 5/9/2014) and AD49582_10 (EXP: 5/16/2014).
Consumers should check their medication for the NDC 00378201777 and the pedigree codes listed above. If the medication matches these details, it should be returned to the pharmacy or contact Aidapak Services for a replacement or refund.
The recalled product
- Product
- ATORVASTATIN CALCIUM, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378201777.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 811
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 (6)
- ATORVASTATIN CALCIUM
- Tablet
- 20 mg has the following codes: Pedigree: AD33897_7
- EXP: 5/9/2014
- Pedigree: AD49582_10
- EXP: 5/16/2014.
Distribution
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.
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