Agency classClass IIOur severity:Moderate FDA (Drugs)·D-624-2014·Announced 2014-01-22

FDA Recalls Cinacalcet HCL Tablets Due to Potential Labeling Mixup

Aidapak Services, LLC is recalling 30 mg Cinacalcet HCL tablets because they may be mislabeled as other medications like acetaminophen or ferrous sulfate.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling mixup, which is a significant risk but does not involve a structural defect or reported fatalities.

Plain-English summary

Aidapak Services, LLC is recalling 600-tablet bottles of Cinacalcet HCL, 30 mg tablets (NDC 55513007330) due to a labeling mixup. The recall is initiated because the product may be potentially mislabeled as other distinct medications, including Acetaminophen Chew Tablets, Ferrous Sulfate Tablets, Omega-3-Acid Ethyl Esters Capsules, and Colchicine.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall covers specific pedigree codes and expiration dates, including W003168 (EXP: 6/13/2014), AD54516_4 (EXP: 5/20/2014), AD32757_50 (EXP: 5/14/2014), W003615 (EXP: 6/25/2014), AD52778_82 (EXP: 5/21/2014), AD73597_13 (EXP: 5/31/2014), W003481 (EXP: 6/20/2014), and W003492 (EXP: 6/20/2014).

Consumers and healthcare providers should check their inventory for these specific NDCs, pedigree codes, and expiration dates. If the product is found, it should be stopped and returned to the distributor or reported to the FDA. Patients should consult their healthcare provider for alternative treatment options if they have been using the affected product.

The recalled product

Product: CINACALCET HCL Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007330
Manufacturer: Aidapak Services, LLC
Category: Drug — Prescription Medication
Hazard: mis-labeling
Affected units: 600

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 (18)

CINACALCET HCL
Tablet
30 mg has the following codes Pedigree: W003168
EXP: 6/13/2014
Pedigree: AD54516_4
EXP: 5/20/2014
Pedigree: AD32757_50
EXP: 5/14/2014
Pedigree: W003615
EXP: 6/25/2014
Pedigree: AD52778_82
EXP: 5/21/2014
Pedigree: AD73597_13
EXP: 5/31/2014
Pedigree: W003481
EXP: 6/20/2014
Pedigree: W003492
EXP: 6/20/2014.

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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Same hazard · mis labeling