The Recall Desk
ModerateFDA (Drugs)·D-625-2014·Announced 2014-01-22

Cinacalcet HCL Tablets Recalled for Potential Labeling Mixup

Aidapak Services is recalling Cinacalcet HCL 60 mg tablets because they may be mislabeled as Ranolazine ER 500 mg.

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, which typically involves a labeling error that could lead to a temporary or medically reversible health consequence. No injuries or illnesses are reported in the source text.

Plain-English summary

Aidapak Services, LLC is recalling Cinacalcet HCL Tablet, 60 mg, NDC 55513007430. The recall is due to a labeling mixup where the product may be potentially mislabeled as Ranolazine ER, Tablet, 500 mg, NDC 61958100301.

The affected product has the pedigree W003742 and an expiration date of 6/26/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their inventory for this specific product and stop using it if it matches the description. They should contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
CINACALCET HCL Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007430
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)

  • CINACALCET HCL
  • Tablet
  • 60 mg has the following code Pedigree: W003742
  • EXP: 6/26/2014.

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

See all →