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.
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 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
- 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
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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