Status
Terminated
Drug Enforcement D-0342-2023
Subpotent Drug
Classification
Class II
Report Date
March 1, 2023
Termination Date
October 31, 2023
Product Information
- Product description
- TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0135-5
- Product quantity
- N/A
- Reason for recall
- Subpotent Drug
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- IBSA PHARMA INC
- Address
-
8 Campus Dr Ste 201, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0342-2023
- Event ID
- 91556
- Recall initiation date
- January 30, 2023
- Center classification date
- April 4, 2023
- Code info
- Lot #: 220414, Exp. 10/2023; 220852, Exp. 02/2024; 220970, Exp. 03/2024.
- More code info
- —