Levothyroxine Sodium Tablets Recalled for Potential Labeling Error
Aidapak Services is recalling Levothyroxine Sodium 175 mcg tablets because they may have been mislabeled as Cinacalcet HCl 60 mg.
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 and involves a labeling error (label mixup) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling Levothyroxine Sodium tablets, 175 mcg, NDC 00074707090. The recall is due to a labeling error where the product may have been mislabeled as Cinacalcet HCl tablets, 60 mg, NDC 55513007430.
The affected product has the pedigree W003743 and an expiration date of 6/26/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication labels and contact their pharmacist or healthcare provider if they have the affected product. Do not take the medication if it is mislabeled.
The recalled product
- Product
- LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074707090.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 90
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)
- LEVOTHYROXINE SODIUM
- Tablet
- 175 mcg has the following codes: Pedigree: W003743
- EXP: 6/26/2014.
Distribution
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.
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