Troubling Healthcare Recalls in 2Q2024

Drug Recalls by the Center for Drug Evaluation and Research (CDER)

Sagent Pharmaceuticals, Docetaxel Injection, USP

Sagent Pharmaceuticals has voluntarily recalled two lots of Docetaxel Injection, USP as the result of a customer complaint due to potential presence of particulate matter from the stopper in the drug product. Intravenous administration of an injectable product that contains particulate matter may result in serious adverse events. Potential complications related to injection of particles include inflammation of a vein, granuloma, and blockage of blood vessels in the heart, lungs, or brain that can cause stroke or life-threatening blood clot events.

To date, Sagent Pharmaceuticals has not received any reports of adverse events related to this recall.

Hospira Inc., Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units

Hospira Inc., a Pfizer company, has voluntarily recalled lots of Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units to the user level.

The recall was initiated due to the potential for incomplete crimp seals; one customer complaint has been received for one leaking unit. If impacted products are administered to a patient, there is a potential for an increased risk of lack of therapeutic effect and systemic infection that may result in the need for additional medical treatment.

To date, Pfizer has not received reports of any relevant adverse events associated with this issue for these lots.

Dr. Reddy’s Laboratories Inc., Sapropterin Dihydrochloride Powder for Oral Solution 100mg

Dr. Reddy’s Laboratories Ltd. has voluntarily recalled six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100mg to the consumer level due to powder discoloration in some packets leading to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints.

Reduced efficacy of the product would result in elevated Phenylalaninemia (Phe) levels in patients. Chronically elevated Phe levels in infants and children are likely to cause permanent neurocognitive deficits. Furthermore, elevated Phe levels during pregnancy are associated with microcephaly and congenital heart disease.

Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events related to this recall to date.

AvKARE LLC, Atovaquone Oral Suspension

AvKARE LLC has voluntarily recalled lot #AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the consumer/user level, due to the potential Bacillus cereus contamination in the product found during stability testing at a third-party lab.

In the immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life-threatening infections.

To date, AvKARE has not received any reports of adverse events related to this recall.

Medical Device Recalls by the Center for Devices and Radiological Health (CDRH)

BioMérieux Inc., VITEK 2 AST kit

BioMérieux has recalled its VITEK 2 AST cards, an Antimicrobial Sensitivity Testing kit, due to a higher concentration of Ceftriaxone antibiotic in two wells.

This kit is used for testing how sensitive bacteria are to antibiotics. Some of the cards have more of the antibiotic Ceftriaxone in two of their wells than they should have. BioMérieux is telling customers about the potential risk of false susceptible and false resistant results and suggesting they use an alternate testing method for all Ceftriaxone results. The use of the affected kit may cause serious adverse health consequences.

There have been no reports of injuries or deaths associated with this issue.

DeRoyal Industries Inc., GeoMed Custom Tracecarts

DeRoyal has recalled certain Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley. The Nurse Assist 16FR Urine Meter Foley is one of the items found within the firm’s Tracecarts. This recall is in direct response to Nurse Assist LLC’s November 6, 2023, recall over sterility concerns. The rest of the items contained in the tracecart are not affected or impacted by this recall.

The use of the affected trays may cause serious adverse health consequences.

There have been no reported injuries and no reports of death.

Product recalls by the Consumer Product Safety Commission (CPSC)

Bausch + Lomb, Watson Eyelid Wipes for Dogs

Bausch + Lomb has recalled Watson Eyelid Wipes for Dogs due to risk of exposure to bacteria and fungi. When the recalled dog eyelid wipes are opened and in use, bacteria and fungi, which are organisms found widely in the environment, soil, and water, can be introduced and grow in the container, posing a risk of serious infection to people with weakened immune systems. Consumers should immediately stop using the recalled eyelid wipes and request a full refund by submitting a picture of their product via an online form at http://eyelidwiperecall.com/.

Product recalls by the Consumer Product Safety Commission (CPSC)

Bausch + Lomb, Watson Eyelid Wipes for Dogs

Bausch + Lomb has recalled Watson Eyelid Wipes for Dogs due to risk of exposure to bacteria and fungi. When the recalled dog eyelid wipes are opened and in use, bacteria and fungi, which are organisms found widely in the environment, soil, and water, can be introduced and grow in the container, posing a risk of serious infection to people with weakened immune systems. Consumers should immediately stop using the recalled eyelid wipes and request a full refund by submitting a picture of their product via an online form at http://eyelidwiperecall.com/.