Synthroid Levothyroxine Tablets Recalled for Incorrect Barcode Labeling
AbbVie is recalling 864 cartons of Synthroid (Levothyroxine Sodium) 125mcg tablets due to incorrect barcode labeling. About 1 in 40 blister packs has a barcode showing 200mcg instead of 125mcg, risking dosage confusion.
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: This is a medication dosage mislabeling issue where barcodes indicate 200mcg instead of the correct 125mcg dose, creating a risk of medication error and potential adverse health effects from levothyroxine dosing errors. Although FDA classified this as Class III and no illnesses have been reported, this constitutes a 'risk-of-harm product' per the rubric.
Plain-English summary
Synthroid (Levothyroxine Sodium) Tablets, USP 125mcg, are being recalled by AbbVie Inc. due to incorrect barcode labeling on certain unit dose blister packs. The issue affects approximately 1 out of every 40 unit dose blister packs, where the barcode incorrectly indicates a 200mcg dose instead of the correct 125mcg dose.
The recalled product is Synthroid Levothyroxine Sodium Tablets, USP 125mcg (0.125mg) in 100-count bottles, NDC 0074-7068-11. The recall involves Lot #1187435 with an expiration date of February 2024, totaling 864 cartons distributed in the United States.
When a pharmacy or healthcare facility scans the affected barcode, the dosage information displayed may be incorrect, potentially causing confusion about the actual dose of the medication being dispensed. Levothyroxine is a prescription thyroid hormone medication that requires accurate dosing.
Patients and healthcare providers with the affected product should verify the actual dose printed on the medication label and package (125mcg) rather than relying on barcode scanning information. Consumers should contact AbbVie Inc. for questions or concerns regarding this recall.
The recalled product
- Product
- SYNTHROID (LEVOTHYROXINE SODIUM)
- Brand
- SYNTHROID
- Manufacturer
- AbbVie Inc.
- Category
- Drug
- Hazard
- barcode-error
- incorrect-dosage
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 (1)
- Lot # 1187435 exp date: 02/2024
UPCs (10)
- 0300747149902
- 0300747068197
- 0300744341194
- 0300745182192
- 0300747070190
- 0300747069903
- 0300749296192
- 0300743727906
- 0300747148905
- 0300746624905
Distribution
Distribution scope not specified by the agency.
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