Status
Terminated
Drug Enforcement D-0353-2023
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Classification
Class II
Report Date
March 8, 2023
Termination Date
March 18, 2024
Product Information
- Product description
- 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.
- Product quantity
- 21,276 bottles
- Reason for recall
- Sub-Potent Drug: Out of specification for assay at the 24 month interval.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- Alvogen, Inc
- Address
-
44 Whippany Rd Ste 107, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0353-2023
- Event ID
- 91654
- Recall initiation date
- February 6, 2023
- Center classification date
- February 24, 2023
- Code info
- Lot # HE02221, Exp. 05/2023
- More code info
- —