Tirosint Solution
FDA Recall NDC 71858-0135

Latest: Class II · Status: Terminated · Initiated Jan 30, 2023 · 15 enforcement reports

Active & Historical Enforcement Reports

The FDA has identified 15 recorded enforcement report(s) associated with Tirosint (NDC 71858-0135). A significant event, classified as Class II, was initiated on Jan 30, 2023 by Ibsa Pharma Inc.. The reported reason for this action was: "Subpotent Drug"

This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.

Reported Recall Events

D-0335-2023TERMINATEDD-0341-2023TERMINATEDD-0345-2023TERMINATEDD-0336-2023TERMINATEDD-0331-2023TERMINATEDD-0344-2023TERMINATEDD-0340-2023TERMINATEDD-0337-2023TERMINATEDD-0338-2023TERMINATEDD-0343-2023TERMINATEDD-0339-2023TERMINATEDD-0334-2023TERMINATEDD-0332-2023TERMINATEDD-0342-2023TERMINATEDD-0333-2023TERMINATED

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0335-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
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
Batch or Lot Expiration Information
Lot# : 220856, Exp. 2/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0341-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
TIROSINT - 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 71858-0125-5
Batch or Lot Expiration Information
Lot# : 220411, Exp. 10/2023; 220854, Exp. 02/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0345-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
TIROSINT - 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 71858-0160-5
Batch or Lot Expiration Information
Lot# : 220418, Exp. 10/2023; 220560, Exp. 11/2023.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0336-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
TIROSINT - 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 71858-0112-5
Batch or Lot Expiration Information
Lot# : 220552, Exp. 11/2023; 221055, Exp. 04/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0331-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
TIROSINT - 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 71858-0105-5
Batch or Lot Expiration Information
Lot# : 220409, Exp. 10/2023; 220956, Exp. 03/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0344-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
TIROSINT - 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 71858-0150-5
Batch or Lot Expiration Information
Lot# : 220959, Exp. 3/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0340-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
TIROSINT - 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 71858-0120-5
Batch or Lot Expiration Information
Lot# : 220853, Exp. 02/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0337-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
TIROSINT - 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 71858-0113-5
Batch or Lot Expiration Information
Lot# : 220553, Exp. 11/2023; 221056, Exp. 04/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0338-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
TIROSINT - 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 71858-0115-5
Batch or Lot Expiration Information
Lot# : 220407, Exp. 10/2023; 220960, Exp. 03/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0343-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
TIROSINT - 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 71858-0145-5
Batch or Lot Expiration Information
Lot# : 220415, Exp. 10/2023; 221052, Exp. 04/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0339-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
TIROSINT - 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 71858-0117-5
Batch or Lot Expiration Information
Lot# : 220556, Exp. 11/2023; 221058, Exp. 04/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0334-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
TIROSINT - 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 71858-0155-5
Batch or Lot Expiration Information
Lot# : 220416, Exp. 10/2023; 221053, Exp. 4/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0332-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
TIROSINT - 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 71858-0130-5
Batch or Lot Expiration Information
Lot# : 220413, Exp. 10/2023; 220964, Exp. 3/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0342-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
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
Batch or Lot Expiration Information
Lot# : 220414, Exp. 10/2023; 220852, Exp. 02/2024; 220970, Exp. 03/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

January 2023 Class II Recall: Subpotent Drug

Recall Number
D-0333-2023
Class II Terminated
Reason for Recall
Subpotent Drug
Initiated
Jan 30, 2023
Reported
Mar 01, 2023
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
91556
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
IBSA PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 31, 2023
Product Description
TIROSINT - 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 71858-0140-5
Batch or Lot Expiration Information
Lot# : 220855, Exp. 2/2024.
Affected Packages Involved in this Recall
71858-0105-6Tirosint Sol
71858-0105-4Tirosint Sol
71858-0105-5Tirosint Sol
71858-0105-1Tirosint Sol
71858-0105-2Tirosint Sol
71858-0110-6Tirosint Sol
71858-0110-4Tirosint Sol
71858-0110-5Tirosint Sol
71858-0110-1Tirosint Sol
71858-0110-2Tirosint Sol
71858-0112-6Tirosint Sol
71858-0112-4Tirosint Sol
71858-0112-5Tirosint Sol
71858-0112-1Tirosint Sol
71858-0112-2Tirosint Sol
71858-0113-6Tirosint Sol
71858-0113-4Tirosint Sol
71858-0113-5Tirosint Sol
71858-0113-1Tirosint Sol
71858-0113-2Tirosint Sol
71858-0115-6Tirosint Sol
71858-0115-4Tirosint Sol
71858-0115-5Tirosint Sol
71858-0115-1Tirosint Sol
71858-0115-2Tirosint Sol
71858-0117-6Tirosint Sol
71858-0117-4Tirosint Sol
71858-0117-5Tirosint Sol
71858-0117-1Tirosint Sol
71858-0117-2Tirosint Sol
71858-0120-6Tirosint Sol
71858-0120-4Tirosint Sol
71858-0120-5Tirosint Sol
71858-0120-1Tirosint Sol
71858-0120-2Tirosint Sol
71858-0125-6Tirosint Sol
71858-0125-4Tirosint Sol
71858-0125-5Tirosint Sol
71858-0125-1Tirosint Sol
71858-0125-2Tirosint Sol
71858-0130-6Tirosint Sol
71858-0130-4Tirosint Sol
71858-0130-5Tirosint Sol
71858-0130-1Tirosint Sol
71858-0130-2Tirosint Sol
71858-0135-6Tirosint Sol
71858-0135-4Tirosint Sol
71858-0135-5Tirosint Sol
71858-0135-1Tirosint Sol
71858-0135-2Tirosint Sol
71858-0140-6Tirosint Sol
71858-0140-4Tirosint Sol
71858-0140-5Tirosint Sol
71858-0140-1Tirosint Sol
71858-0140-2Tirosint Sol
71858-0145-6Tirosint Sol
71858-0145-4Tirosint Sol
71858-0145-5Tirosint Sol
71858-0145-1Tirosint Sol
71858-0145-2Tirosint Sol
71858-0150-6Tirosint Sol
71858-0150-4Tirosint Sol
71858-0150-5Tirosint Sol
71858-0150-1Tirosint Sol
71858-0150-2Tirosint Sol
71858-0155-6Tirosint Sol
71858-0155-4Tirosint Sol
71858-0155-5Tirosint Sol
71858-0155-1Tirosint Sol
71858-0155-2Tirosint Sol
71858-0160-6Tirosint Sol
71858-0160-4Tirosint Sol
71858-0160-5Tirosint Sol
71858-0160-1Tirosint Sol
71858-0160-2Tirosint Sol

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.