FDA Recall/Drug Shortage Roundup (1/31/2025)

We are on day 10 of the external communications pause from the FDA. What has been recalled? What drug shortages have been announced?

Today is day 10 of a pause on communications from federal health agencies. Drug shortages and discontinuations have been added to this daily update.

Keep in mind that the medications on this list may have multiple manufacturers producing the same medication, so it does not mean that it will be impossible to get your medication if it is listed as a discontinuation, but there may be a relative shortage. If you are struggling to find your medications, please talk with your doctor and pharmacist right away. The public can also report a drug shortage here.

Hopefully, this the last recall alert I will make, but if the external communication pause is still in effect on Monday, I will send another post then.

Food and Drug Recall summary

Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System

Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal system is manufactured by Kindeva Drug Delivery L.P., Northridge, CA and is distributed by Alvogen, Inc. as a private label distributor.

There is a possibility that the application of a multi-stacked 25 mcg/h patch could result in serious, life threatening, or fatal respiratory depression. Groups at potential increased risk could include first-time recipients of such patches, children, and the elderly. To date, Alvogen has received one serious adverse event related to this recall.

The product is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an extended treatment period with a daily opioid analgesic in opioid-tolerant patients, and for which alternative treatment options are inadequate, and is packaged in primary cartons of five individually wrapped and labeled pouches. The affected Fentanyl Transdermal System lot is:

Lot 108319 of Fentanyl Transdermal System, 25 mcg/h, expiration date 04/2027.

This lot of Fentanyl Transdermal System was distributed nationwide to the pharmacy and patient level. See image examples for lot 108319 and a multi-stacked patch.

Alvogen, Inc. is notifying its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products. Pharmacies are requested not to dispense any product subject to this recall.

Patients that have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Questions regarding this recall should be directed to Alvogen Customer Complaints by calling 866-770-3024 or sending an e-mail to alvogensmb@continuumindia.com, Monday to Friday from 9:00 am to 5:00 pm EST.

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: www.fda.gov/medwatch/report.htm

• Regular Mail or Fax: Download 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 U.S. Food and Drug Administration.

Blue Ridge Beef Issues a Recall of Blue Ridge Beef Natural Mix Due to Salmonella Contamination

STATESVILLE, NC – January 31, 2025– Blue Ridge Beef is recalling 5,700 lbs. of their 2 lb log Natural Mix due to a contamination of Salmonella. Lot # N25/12/31 (Lot numbers are stamped in the clips on the end of the chubs/bags) UPC# 854298001054.

Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever, and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

Samples of the product was collected on 01/08/25 by the North Carolina Department of Agriculture and tested by the North Carolina Department of Agriculture Food and Drug Protection Laboratory. The product tested positive for Salmonella.

On 01/27/2025 the firm was notified by the FDA that the product tested positive for Salmonella.

The products were distributed between January 3/2025 to January 24/2025. The product is packaged in clear plastic and sold primarily in retail stores located in the States of: [Virginia, Maryland, Pennsylvania, Connecticut, Massachusetts, New York State, Tennessee, Rhode Island. Image of product below:

Consumers who have purchased this product are urged to return to place of purchase or destroy the food in a way that children, pets, and wildlife cannot access. Do not sell or donate the recalled products. Do not feed the recalled product to pets or any other animals. Wash and sanitize pet food bowls, cups, and storage containers. Always ensure you wash and sanitize your hands after handling recalled food or any utensils that come in contact with recalled food. For more information contact blueridgebeefnc@yahoo.com or 704-873-2072

This recall is being made with the knowledge of the Food and Drug Administration.

Drug shortage summary

As a reminder, if the drug says it is discontinued it does not necessarily mean that it is gone completely. Many companies produce the same drugs so there may be a relative shortage though.

No new updates as of 1/31/25 at 5PM EST.

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