FDA Recalls Levothyroxine Sodium Tablets Due to Potential Labeling Errors
Aidapak Services is recalling Levothyroxine Sodium 175 mcg tablets because they may have been mislabeled as other medications.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to the 'Severe' severity level in the rubric. Mislabeling of prescription drugs poses a significant risk of incorrect dosing or medication errors.
Plain-English summary
Aidapak Services, LLC is recalling Levothyroxine Sodium tablets, 175 mcg, NDC 00527135001. The recall is due to a labeling error where the product may have been mislabeled as Levothyroxine Sodium 88 mcg tablets or hydroxyzine pamoate 100 mg capsules.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves specific lots with pedigree AD46265_37 (expiration 5/15/2014) and W003009 (expiration 6/11/2014).
Patients and healthcare providers should check their medication labels and consult their pharmacist or physician if they have received the affected product. This recall is classified as FDA Class II.
The recalled product
- Product
- LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527135001.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 200
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 (6)
- LEVOTHYROXINE SODIUM
- Tablet
- 175 mcg has the following codes: Pedigree: AD46265_37
- EXP: 5/15/2014
- Pedigree: W003009
- EXP: 6/11/2014.
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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