FDA Recalls Potentially Mislabeled Levothyroxine/Liothyronine Tablets
Aidapak Services is recalling Levothyroxine/Liothyronine tablets that may be mislabeled as Magnesium Gluconate Dihydrate.
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/Liothyronine Tablets, 19 mcg/4.5 mcg, which may be potentially mislabeled as Magnesium Gluconate Dihydrate Tablets, 500 mg. The affected product is identified by NDC 42192032901, Pedigree AD30197_19, and an expiration date of 3/31/2014.
The recall was initiated due to a label mixup. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for the specific pedigree and expiration date listed above. If the product matches the description, they should contact their pharmacist or healthcare provider for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- LEVOTHYROXINE/ LIOTHYRONINE Tablet, 19 mcg/4.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42192032901
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Thyroid Medication
- Hazard
- Affected units
- 102
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 (3)
- LEVOTHYROXINE/ LIOTHYRONINE Tablet
- 19 mcg/4.5 mcg has the following code Pedigree: AD30197_19
- EXP: 3/31/2014.
Distribution
Part of a larger recall action
This product is one of 273 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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