The Recall Desk
ModerateFDA (Drugs)·D-792-2014·Announced 2014-01-29

Cilostazol Tablets Recalled for Potential Label Mixup with Calcium Acetate

Aidapak Services is recalling Cilostazol 100 mg tablets due to a potential label mixup with Calcium Acetate capsules. The repacked drugs were distributed in four western states.

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 error (label mixup) without reported injuries or illnesses, which aligns with the rubric for moderate severity involving minor labeling errors or low-risk contamination.

Plain-English summary

Aidapak Services, LLC is recalling Cilostazol, Tablet, 100 mg, NDC 00054004421, due to a labeling error. The product may be potentially mislabeled as Calcium Acetate, Capsule, 667 mg, NDC 00054008826. The specific pedigree for the recalled Cilostazol is W003470, with an expiration date of 6/20/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as Class II by the FDA, 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 Cilostazol tablets with pedigree W003470 and expiration date 6/20/2014. If found, these products should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding their medication.

The recalled product

Product
CILOSTAZOL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054004421.
Affected units
60

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)

  • CILOSTAZOL
  • Tablet
  • 100 mg has the following codes: Pedigree: W003470
  • EXP: 6/20/2014.

Distribution

Distributed in 4 states:

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.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

See all →