Aidapak Recalls Atorvastatin Calcium Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling 80 mg Atorvastatin Calcium tablets because they may have been mislabeled as other prescription 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of administering incorrect prescription medications.
Plain-English summary
Aidapak Services, LLC is recalling Atorvastatin Calcium tablets, 80 mg, distributed in Arizona, California, Oregon, and Washington. The recall is due to a labeling error where the medication may have been mislabeled as Omega-3 Fatty Acid, Tacrolimus, or Levothyroxine Sodium.
The affected product is identified by NDC 00378212277 and includes specific pedigree codes and expiration dates listed in the agency notice. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific pedigree codes and expiration dates mentioned in the official notice. If the product is found, it should be returned to the distributor or disposed of according to local regulations.
The recalled product
- Product
- ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378212277.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 270
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 (8)
- ATORVASTATIN CALCIUM
- Tablet
- 80 mg has the following codes: Pedigree: AD73627_1
- EXP: 5/30/2014
- Pedigree: W003213
- EXP: 6/14/2014
- Pedigree: AD46300_1
- EXP: 5/15/2014.
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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