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.
