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-0335-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0341-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0342-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0333-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0340-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0337-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0338-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0334-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0332-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0345-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0336-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0343-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0339-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0344-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated
D-0331-2023	01-30-2023	03-01-2023	Class II	N/A	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	Subpotent Drug	Terminated

Recalled Products

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

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0335-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220856, Exp. 2/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0341-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220411, Exp. 10/2023; 220854, Exp. 02/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0342-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220414, Exp. 10/2023; 220852, Exp. 02/2024; 220970, Exp. 03/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0333-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220855, Exp. 2/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0340-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220853, Exp. 02/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0337-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220553, Exp. 11/2023; 221056, Exp. 04/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0338-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220407, Exp. 10/2023; 220960, Exp. 03/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0334-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220416, Exp. 10/2023; 221053, Exp. 4/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0332-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220413, Exp. 10/2023; 220964, Exp. 3/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0345-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220418, Exp. 10/2023; 220560, Exp. 11/2023. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0336-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220552, Exp. 11/2023; 221055, Exp. 04/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0343-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220415, Exp. 10/2023; 221052, Exp. 04/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0339-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220556, Exp. 11/2023; 221058, Exp. 04/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0344-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220959, Exp. 3/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	91556 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0331-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-01-2023
Recall Initiation Date	01-30-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-31-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	IBSA PHARMA INC
Code Info	Lot #: 220409, Exp. 10/2023; 220956, Exp. 03/2024. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	71858-0105-6; 71858-0105-4; 71858-0105-5; 71858-0105-1; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.