Aidapak Recalls Levothyroxine Sodium Tablets Due to Labeling Errors
Aidapak Services, LLC is recalling Levothyroxine Sodium 88 mcg tablets because they may have been mislabeled as other prescription drugs.
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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving potential mislabeling of prescription drugs, which could lead to incorrect treatment, are categorized as Severe.
Plain-English summary
Aidapak Services, LLC is voluntarily recalling Levothyroxine Sodium, Tablet, 88 mcg (NDC 00378180701) due to a labeling error. The recall was initiated because the tablets may have been mislabeled as other medications, including Nebivolol HCL, Melatonin, Isosorbide Dinitrate, and Hydrocortisone.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall covers 600-tablet units with specific pedigree codes and expiration dates ranging from May to June 2014. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers should stop using the affected Levothyroxine Sodium tablets and contact their pharmacist or physician for a replacement. Consumers should check their medication packaging for the NDC 00378180701 and the specific pedigree codes listed in the recall notice to determine if their medication is affected.
The recalled product
- Product
- LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378180701.
- 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 (12)
- LEVOTHYROXINE SODIUM
- Tablet
- 88 mcg has the following codes: Pedigree: AD73652_10
- EXP: 5/30/2014
- Pedigree: W003047
- EXP: 6/12/2014
- Pedigree: W003476
- EXP: 6/20/2014
- Pedigree: W002967
- EXP: 6/11/2014
- Pedigree: AD42584_1
- EXP: 5/14/2014.
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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