Recalls That Should Be on Your Radar—Week of February 24, 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:

ICU Medical Recalls Lots of ChemoLock and ChemoClave due to Potential for Burr Particulate

ICU Medical, Inc. today announced a voluntary recall of certain lots of ChemoLock™ and ChemoClave® Vial Spikes due to the potential for burr particulate originating from the protective cap used in the assembly of the device. The affected product lot was distributed nationwide to ICU Medical customers between August 2018 and February 2019.

The FDA is classifying this as a Class 1 recall, as burr particulate has the potential to detach and, in rare circumstances, enter the fluid path causing an embolism that may damage organs or lead to a stroke, resulting in serious injury or death. To date, ICU Medical has not received any reports of adverse events related to this matter and is issuing this notification out of an abundance of caution.

To read more about this recall, consult the news release.

Golean Detox USA Recalls DETOX Capsules Due to Sibutramine and Phenolphthalein

Golean Detox USA, Charlotte, NC is voluntarily recalling all lots within expiry of Golean DETOX capsules to the consumer level. FDA analysis has found Golean DETOX capsules to be tainted with undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the United States. The presence of sibutramine and phenolphthalein in Golean DETOX renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

For more information on this recall, read the press release.

Southern Specialties Recalls Green Bean and Squash Products due to Potential Listeria Contamination

Southern Specialties Inc. of Pompano Beach, Florida is voluntarily recalling select bags of Marketside brand green beans and butternut squash because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The company shipped the recalled product to one retail distribution center. Although most of the product was retrieved before distribution to retail stores, some product shipped on February 17th may have reached select stores in Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee and Virginia. So, in an abundance of caution, we are issuing this public announcement.

For a list of recalled products, check out the announcement.

McAllen Cold Storage Recalls Siluriformes Fish Products Without Benefit of Inspection

McAllen Cold Storage, Ltd., a McAllen, Texas establishment, is recalling approximately 51,942 pounds of frozen Siluriformes fish products, specifically Basa fillets, that were not presented for import re-inspection into the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen Basa fillet items were imported from Vietnam to the United States on various dates from Aug. 1, 2018 to Feb. 15, 2019.

Learn more by consulting the FDA’s statement.

Sahlen Packing Company Recalls Deli Meat Products Due To Potential Extraneous Material Contamination

Sahlen Packing Company, Inc., a Buffalo, N.Y. establishment, is recalling approximately 13,224 pounds of ready-to-eat (RTE) deli ham products that may be contaminated with extraneous materials, specifically plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The RTE deli ham items were produced on January 25, 2019.

Check out the news release.

Losartan Tablet Recall Expanded

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted 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, Unit — I (API manufacturer).

NMBA is a potential human carcinogen. To date, Camber 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, 90ct, 500ct, 1000ct bottles. The identifying NDC #s associated with Camber’s product as are follows: Losartan 25 mg 31722-700-90, 31722-700-05, 31722-700-10; Losartan 50 mg 31722-701-30, 31722-701-90, 31722-70-10; and Losartan 100 mg 31722-702-30, 31722-702-90, and 31722-702-10.

Read more here.

Valsartan Amlodipine Tablet Recall Expanded

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug producAurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. The expansion relates to lots distributed under the labels for AurobindoPharma USA, Inc. and Acetris Health, LLC. To date, AurobindoPharma USA, Inc. has not received any reports of adverse events related to this recall.

The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Additional details are available in the press release.

LIFEPAK15 Monitor/Debrillator Recalled Due to Risk of Device Lockup

Physio-Control is recalling its LIFEPAK 15 Monitor/Defibrillator because the device may "lockup" (freeze) after a shock is delivered. When this occurs, the device's monitor display goes blank and there is no response from the keypad or the device although the device's LED lights remain on and indicates the device still has power.

Once the LIFEPAK 15 freezes, it cannot provide defibrillation therapy until the device is reset by restarting the device or removing and reinserting all connected power sources. The resulting delay in delivering a shock could and has resulted in serious patient injury including death.

Learn more in the MedWatch announcement.