Recalls / Class II
Class IID-0353-2023
Product
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.
- Brand name
- Levothyroxine Sodium
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 47781-640, 47781-643, 47781-646, 47781-649, 47781-651, 47781-654, 47781-657, 47781-659, 47781-662, 47781-665 +2 more
- FDA application
- NDA021116
- Affected lot / code info
- Lot # HE02221, Exp. 05/2023
Why it was recalled
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Recalling firm
- Firm
- Alvogen, Inc
- Manufacturer
- Alvogen, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 44 Whippany Rd Ste 107, N/A, Morristown, New Jersey 07960-4558
Distribution
- Quantity
- 21,276 bottles
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2023-02-06
- FDA classified
- 2023-02-24
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-03-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0353-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.