The Recall Desk
ModerateFDA (Drugs)·D-524-2014·Announced 2014-01-22

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.

What this means for you

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
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

Distributed in 4 states:

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.

See all 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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