Aidapak Recalls Atorvastatin Calcium Tablets Due to Labeling Error
Aidapak Services, LLC is recalling 40 mg atorvastatin calcium tablets that may have been mislabeled as 10 mg atorvastatin or 5 mg finasteride.
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 (label mixup) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling 810 tablets of Atorvastatin Calcium, 40 mg, NDC 00378212177. The recall was initiated because the medication may have been mislabeled as Atorvastatin Calcium, 10 mg, or Finasteride, 5 mg.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves specific pedigree codes AD33897_10 and W003096 with expiration dates of May 9, 2014, and June 13, 2014, respectively.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree codes listed in the recall notice. If the medication is found, it should be returned to the distributor or disposed of according to local regulations.
The recalled product
- Product
- ATORVASTATIN CALCIUM, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378212177 .
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 810
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
- 40 mg has the following codes: Pedigree: AD33897_10
- EXP: 5/9/2014
- Pedigree: W003096
- EXP: 6/13/2014.
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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