Aidapak Recalls Levothyroxine Sodium Tablets Due to Labeling Errors
Aidapak Services, LLC is recalling Levothyroxine Sodium 112 mcg tablets because they may have been mislabeled as other drugs. The repacked drugs were distributed in four western states.
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 source text identifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they pose a temporary or medically reversible health risk, such as receiving the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling Levothyroxine Sodium, Tablet, 112 mcg (NDC 00378181101) due to a labeling error. The recall involves 499 tablets that were repacked and distributed in Arizona, California, Oregon, and Washington. The specific lot codes and expiration dates for the recalled product are listed in the source metadata.
The FDA classified this as a Class II recall because the Levothyroxine Sodium tablets may have been mislabeled as other medications, including Zinc Sulfate, Hydralazine HCl, or Cholecalciferol. This mix-up could lead to patients receiving the wrong medication.
Patients who have received these specific tablets should contact their healthcare provider or pharmacist for guidance on how to proceed. The recall is limited to the specific pedigree codes and expiration dates identified in the official notice.
The recalled product
- Product
- LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378181101.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 499
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
- 112 mcg has the following codes: Pedigree: AD60211_1
- EXP: 5/21/2014
- Pedigree: AD52778_37
- EXP: 5/20/2014
- Pedigree: W003847
- EXP: 6/27/2014
- Pedigree: AD30197_13
- EXP: 5/9/2014
- Pedigree: AD49423_7
- EXP: 5/16/2014.
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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