FDA Recalls Levothyroxine Sodium Tablets Due to Potential Labeling Error
Aidapak Services is recalling Levothyroxine Sodium 88 mcg tablets because they may have been mislabeled as Guanfacine HCl 1 mg tablets.
What this means for you
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 potential mislabeling of a prescription drug, which poses a risk of incorrect medication administration. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Levothyroxine Sodium, Tablet, 88 mcg, distributed by Aidapak Services, LLC. The recall is due to a labeling error where the product may have been mislabeled as Guanfacine HCl, Tablet, 1 mg.
The affected product is identified by NDC 00527134401, Pedigree W003010, and an expiration date of 6/12/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients who have received this medication should contact their healthcare provider or pharmacist for guidance. They should not stop taking their medication without consulting a medical professional. The recall is limited to the specific lot identified in the notice.
The recalled product
- Product
- LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134401.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 100
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 (4)
- LEVOTHYROXINE SODIUM
- Tablet
- 88 mcg has the following codes: Pedigree: W003010
- EXP: 6/12/2014.
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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