Levothyroxine Sodium Tablets Recalled for Potential Label Mixup
Aidapak Services is recalling Levothyroxine Sodium tablets that may have been mislabeled as Pramipexole Di-HCl.
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 due to a labeling error (label mixup) which is a minor labeling error with no reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Aidapak Services, LLC is recalling Levothyroxine Sodium, Tablet, 175 mcg (NDC 00378181701) due to a potential label mixup. The recalled product may have been mislabeled as Pramipexole Di-HCl, Tablet, 1 mg (NDC 16714058701). The specific pedigree for the recalled Levothyroxine Sodium is W003151, with an expiration date of 6/13/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The agency has classified this recall as Class II, indicating that 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 Levothyroxine Sodium tablets with pedigree W003151 and expiration date 6/13/2014. If found, these products should be quarantined and returned to the distributor or manufacturer for further instructions.
The recalled product
- Product
- LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378181701
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 100
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: W003151
- EXP: 6/13/2014.
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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