Liothyronine Sodium Tablets Recalled for Potential Labeling Mixup
Aidapak Services is recalling Liothyronine Sodium 25 mcg tablets because they may have been mislabeled as Levothyroxine Sodium or Hyoscyamine Sulfate.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a labeling mixup of prescription drugs, which poses a risk of harm if the wrong medication is administered, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Aidapak Services, LLC is recalling Liothyronine Sodium, Tablet, 25 mcg (NDC 00574022201) due to a labeling error. The source text indicates that the recalled tablets may have been mislabeled as either Levothyroxine Sodium, Tablet, 175 mcg (NDC 00378181701) or Hyoscyamine Sulfate SL, Tablet, 0.125 mg (NDC 00574025001). This mixup could result in patients receiving the wrong medication or dosage.
The affected product consists of 200-tablet bottles. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates associated with the recall include Pedigree W003152 and W003001, both with an expiration date of 4/30/2014.
Consumers and healthcare providers should check their inventory for Liothyronine Sodium 25 mcg tablets with the specified NDC and pedigree codes. If the product is found, it should be returned to the pharmacy or healthcare provider for replacement or refund. Patients should consult their healthcare provider if they have questions about their medication.
The recalled product
- Product
- LIOTHYRONINE SODIUM, Tablet, 25 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574022201.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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)
- LIOTHYRONINE SODIUM
- Tablet
- 25 mcg has the following codes: Pedigree: W003152
- EXP: 4/30/2014
- Pedigree: W003001
- EXP: 4/30/2014.
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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