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- FDA Recall: Tirosint Sol
FDA Recall Tirosint Sol
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on January 30th, 2023 and classified as a Class II recall due to subpotent drug This recall is currently terminated, and the associated recall number is recall number is D-0345-2023. It pertains to Tirosint Sol identified by 71858-0135 as of 10-31-2023 .
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-0345-2023 | 01-30-2023 | 03-01-2023 | 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 | 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-0340-2023 | 01-30-2023 | 03-01-2023 | 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 | 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-0331-2023 | 01-30-2023 | 03-01-2023 | 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 |
| D-0334-2023 | 01-30-2023 | 03-01-2023 | 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-0343-2023 | 01-30-2023 | 03-01-2023 | 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-0332-2023 | 01-30-2023 | 03-01-2023 | 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-0338-2023 | 01-30-2023 | 03-01-2023 | 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-0344-2023 | 01-30-2023 | 03-01-2023 | 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-0342-2023 | 01-30-2023 | 03-01-2023 | 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 | 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-0335-2023 | 01-30-2023 | 03-01-2023 | 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 | 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-0339-2023 | 01-30-2023 | 03-01-2023 | 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 |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
Recall Enforcement Report D-0345-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0336-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0340-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0337-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0331-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0334-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0343-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0332-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0338-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0344-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0342-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0333-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0335-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0341-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
Recall Enforcement Report D-0339-2023
- 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; 71858-0105-2; 71858-0110-6; 71858-0110-4; 71858-0110-5; 71858-0110-1; 71858-0110-2; 71858-0112-6; 71858-0112-4; 71858-0112-5; 71858-0112-1; 71858-0112-2; 71858-0113-6; 71858-0113-4; 71858-0113-5; 71858-0113-1; 71858-0113-2; 71858-0115-6; 71858-0115-4; 71858-0115-5; 71858-0115-1; 71858-0115-2; 71858-0117-6; 71858-0117-4; 71858-0117-5; 71858-0117-1; 71858-0117-2; 71858-0120-6; 71858-0120-4; 71858-0120-5; 71858-0120-1; 71858-0120-2; 71858-0125-6; 71858-0125-4; 71858-0125-5; 71858-0125-1; 71858-0125-2; 71858-0130-6; 71858-0130-4; 71858-0130-5; 71858-0130-1; 71858-0130-2; 71858-0135-6; 71858-0135-4; 71858-0135-5; 71858-0135-1; 71858-0135-2; 71858-0140-6; 71858-0140-4; 71858-0140-5; 71858-0140-1; 71858-0140-2; 71858-0145-6; 71858-0145-4; 71858-0145-5; 71858-0145-1; 71858-0145-2; 71858-0150-6; 71858-0150-4; 71858-0150-5; 71858-0150-1; 71858-0150-2; 71858-0155-6; 71858-0155-4; 71858-0155-5; 71858-0155-1; 71858-0155-2; 71858-0160-6; 71858-0160-4; 71858-0160-5; 71858-0160-1; 71858-0160-2
- 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.
