Recalls That Should Be on Your Radar—Week of April 21, 2019

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Alvogen Inc. Issues Recall of Fentanyl Transdermal System Due to Product Mislabeling

Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level. A small number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches. The 50 mcg/h patches that were included in cartons labeled 12 mcg/h are individually labeled as 50 mcg/h. This transdermal system is manufactured by 3M Drug Delivery Systems, St. Paul, MN.

Application of a 50 mcg/h patch instead of a prescribed 12 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 Inc. has not received any reports of adverse events related to this issue.

The product is indicated for the management of pain in opioid tolerant patients and is packaged in primary cartons of five individually wrapped and labeled pouches.

Learn more about this recall here.

K2D Foods Issues Recall for Ground Beef due to Possible E coli O103 Contamination

K2D Foods, doing business as (DBA) Colorado Premium Foods, a Carrolton, Ga. establishment, is recalling approximately 113,424 pounds of raw ground beef products that may be contaminated with E. coli O103, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The products subject to recall bear establishment number “EST. 51308” inside the USDA mark of inspection on the boxes. These items were shipped to distributors in Port Orange, Fla. and Norcross, Ga. for further distribution to restaurants.

FSIS and its public health partners, including the Centers for Disease Control and Prevention (CDC) and the Tennessee Department of Health, have been investigating an outbreak of E. coli O103. Unopened, intact ground beef collected as part of the ongoing investigation from a restaurant location, where multiple case-patients reported dining, tested positive for E. coli O103. At this time, there is no definitive link between this positive product and the ongoing E. coli O103 outbreak. Further traceback and product analysis continues to determine if the recalled products are related to the E. coli O103 outbreak.

Read more about the recall here and more about the outbreak here.

Grant Park Packing Recalls Ground Beef Products Due Possible E coli O103 Contamination

Grant Park Packing, a Franklin Park, Ill. establishment, is recalling approximately 53,200 pounds of raw ground beef products that may be contaminated with E. coli O103, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The bulk raw ground beef was produced on October 30-31, 2018 and November 1, 2018.

The products subject to recall bear establishment number “EST. 21781” inside the USDA mark of inspection. These items were shipped to Minnesota for further distribution and Kentucky for institutional use.

FSIS and its public health partners, including the Centers for Disease Control and Prevention (CDC) and the Kentucky Department for Public Health, have been investigating an outbreak of E. coli O103. Unopened, intact, packages of ground beef collected as part of the ongoing investigation tested positive for E. coli O103 at an FSIS laboratory. The sample was collected at a point of service where multiple case patients ate. At this time, there is no definitive link between this positive product and the ongoing E. coli O103 outbreak. Further traceback and product analysis continues to determine if the recalled products are related to the E. coli O103 outbreak.

Many clinical laboratories do not test for non-O157 STEC, such as O103 because it is harder to identify than STEC O157:H7. People can become ill from STECs 2—8 days (average of 3–4 days) after exposure to the organism.

Read more about the recall here and more about the outbreak here.

Legacy Pharmaceutical Packaging, LLC Expands Recall of Losartan Potassium

Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall.

Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles.

Read more about this recall here.