Recall Enforment Report D-0335-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by IBSA PHARMA INC, originally initiated on 01-30-2023 for the product TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 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 71858-0110-5 The product was recalled due to subpotent drug. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0335-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 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 71858-0110-5Subpotent DrugTerminated
D-0341-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 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 71858-0125-5Subpotent DrugTerminated
D-0342-202301-30-202303-01-2023Class IIN/ATIROSINT - 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 71858-0135-5Subpotent DrugTerminated
D-0333-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 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 71858-0140-5Subpotent DrugTerminated
D-0345-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 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 71858-0160-5Subpotent DrugTerminated
D-0336-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 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 71858-0112-5Subpotent DrugTerminated
D-0340-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 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 71858-0120-5Subpotent DrugTerminated
D-0337-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 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 71858-0113-5Subpotent DrugTerminated
D-0338-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 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 71858-0115-5Subpotent DrugTerminated
D-0334-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 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 71858-0155-5Subpotent DrugTerminated
D-0332-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 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 71858-0130-5Subpotent DrugTerminated
D-0343-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 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 71858-0145-5Subpotent DrugTerminated
D-0339-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 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 71858-0117-5Subpotent DrugTerminated
D-0344-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 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 71858-0150-5Subpotent DrugTerminated
D-0331-202301-30-202303-01-2023Class IIN/ATIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 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 71858-0105-5Subpotent DrugTerminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
71858-0105Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0110Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0112Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0113Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0115Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0117Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0120Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0125Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0130Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0135Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0140Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0145Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0150Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0155Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug
71858-0160Tirosint SOLLevothyroxine SodiumSolutionOralIbsa Pharma Inc.Human Prescription Drug