VistaPharm Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus

Date: 09/22/2023

At Prime Therapeutics Management, we want to help you receive the best possible care. Visit our drug recall site for details: https://www.primetherapeutics.com/en/drugrecalls.

About this recall:
VistaPharm is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product. For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.
The product is used as an antiulcer therapeutic and is packaged in a 16oz (414mL) PET Bottle with NDC 66689-305-16. The affected Sucralfate Oral Suspension lot is number 810300 with an expiration Date of October 31, 2023. The product can be identified with its product name Sucralfate Oral Suspension 1g per 10mL, with the product Lot No 810300 and expiration date of October 31, 2023, at the bottom right side of label. This Sucralfate Oral Suspension Lot was distributed Nationwide to three (3) distributors by wholesale.

What this means to you:
Consumers with questions regarding this recall can contact Inmar at 1-800-967-5952 or by email to rxrecalls@Inmar.com. Office hours are 9am to 5pm EST Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report online.
• Regular Mail or Fax: Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA- 0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

Scynexis Issues a Voluntary Nationwide Recall of Brexafemme® (ibrexafungerp tablets) Due to Potential for Cross Contamination with a Non-Antibacterial ßlactam Drug Substance

Date: 09/28/2023

At Prime Therapeutics Management, we want to help you receive the best possible care. Visit our drug recall site for details: https://www.primetherapeutics.com/en/drugrecalls.

About this recall:
Scynexis is conducting a voluntary nationwide recall of 2 lots of Brexafemme (ibrexafungerp tablets) to the consumer level in the US market due to potential cross contamination with a non- antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the Brexafemme tablets. During a review of manufacturing equipment and cleaning activities at a supplier, SCYNEXIS Scynexis was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance. This press release provides additional details on the voluntary product recall recently disclosed by Scynexis.

The potential cross contamination with a non-antibacterial beta-lactam drug substance could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction. To date, Scynexis has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination.

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.

Brexafemme is an antifungal product indicated for the treatment of vulvovaginal candidiasis (VVC) and the reduction of the incidence of recurrent vulvovaginal candidiasis (RVVC). Brexafemme is dispensed in a carton and packaged in blister packs with four 150-mg tablets (NDC 75788-115-04). Brexafemme tablet for oral administration is a purple, oval, biconvex shaped, film-coated tablet debossed with 150 on one side and SCY on the other side. The affected Brexafemme lots include the following lots and expiration dates: LF21000008 (expiration date 11/2023) and LF22000051 (expiration date 11/2025). The recalled lots were distributed nationwide to wholesalers across the US, beginning in December 2022.

What this means to you:
Consumers with questions regarding this recall can contact Sedgwick at 1-877-551-7154. Office hours: Monday to Friday, 8:00 AM to 5:00 PM ET.

Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report online.
• Regular Mail or Fax: Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA- 0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization

Date: 09/11/2023

At Prime Therapeutics Management, we want to help you receive the best possible care. Visit our drug recall site for details: https://www.primetherapeutics.com/en/drugrecalls.

About this recall:
Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune formulations are impacted.

Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

The affected lot number and expiration date is: FX001691 (expiration date 12/2025). This lot was distributed nationwide to wholesalers across the US, beginning in April 2023.

What this means to you:
Novartis is notifying its distributors via a recall notification letter and is arranging for return of the recalled lot from distributors, retailers and consumers. Additionally, Novartis is notifying health care providers who have prescribed this product to contact their patients. Consumers that have bottles from the recalled lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL, should contact their health care provider.

In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their health care provider and Novartis to report the event or finding. Patients or health care providers may call the Novartis customer interaction center at 888-NOW-NOVA (888-669-6682) from 8:30 AM – 5:00 PM ET Monday through Friday or may report an adverse event through https://www.novartis.com/reportExternal Link Disclaimer or usdrugsafety.operations@novartis.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report online.
• Regular Mail or Fax: Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA- 0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.

Marlex Pharmaceuticals Issues Voluntary Nationwide Recall of Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg Due to Label Mix-Up

Date: 08/31/2023

At Prime Therapeutics Management, we want to help you receive the best possible care. Visit our drug recall site for details: https://www.primetherapeutics.com/en/drugrecalls.

About this recall:
VistaPharm is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product. For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on the link to the FDA Recall Notification found below.
The product is used as an antiulcer therapeutic and is packaged in a 16oz (414mL) PET Bottle with NDC 66689-305-16. The affected Sucralfate Oral Suspension lot is number 810300 with an expiration Date of October 31, 2023. The product can be identified with its product name Sucralfate Oral Suspension 1g per 10mL, with the product Lot No 810300 and expiration date of October 31, 2023, at the bottom right side of label. This Sucralfate Oral Suspension Lot was distributed Nationwide to three (3) distributors by wholesale.

What this means to you:
Consumers with questions regarding this recall can contact Inmar at 1-800-967-5952 or by email to rxrecalls@Inmar.com. Office hours are 9am to 5pm EST Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report online.
• Regular Mail or Fax: Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA- 0178.

This recall is being conducted with the knowledge of the United States (US) Food and Drug Administration.