Aidapak Recalls Simvastatin Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling 20 mg Simvastatin tablets because they may be mislabeled as Vitamin B Complex with C/Folic Acid.
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 between two distinct products. This fits the rubric for moderate severity, as it is a labeling error without reported injuries or deaths.
Plain-English summary
Aidapak Services, LLC is recalling 1,000 tablets of SIMVASTATIN Tablet, 20 mg (NDC 16714068303) due to a labeling error. The recall is initiated because the product may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet (NDC 60258016001).
The affected product has the pedigree W003580 and an expiration date of 6/24/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer for disposal.
The recalled product
- Product
- SIMVASTATIN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714068303
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,000
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)
- SIMVASTATIN
- Tablet
- 20 mg has the following code Pedigree: W003580
- EXP: 6/24/2014.
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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