Two Injectable Drug Products Recalled Due to Sterility Concerns
May 28, 2019 – Heritage Pharmaceuticals has announced a voluntary recall of one lot of Amikacin Sulfate Injection USP 1g/4mL (250mg/mL), and one lot of Prochlorperazine Edisylate Injection USP 10mg/2mL (5mg/mL). Both products are manufactured by Emcure Pharmaceuticals and distributed by Heritage. Heritage issued the voluntary recall due to the detection of microbial growth that may indicate a lack of sterility in the products.
The use of a non-sterile product that was intended to be sterile can result in infection, which could lead to hospitalization, organ damage, or death. As of the date of the recall, Heritage has received no reports of adverse events.
Amikacin Sulfate Injection is indicated to provide short-term treatment for serious infections due to susceptible strains of Gram-negative bacteria. Prochlorperazine Edisylate Injection is indicated to control severe nausea and vomiting and to treat schizophrenia.
Heritage has advised consumers to stop taking the affected medications and speak with their healthcare providers about stopping treatment and the possibility of switching to an alternative therapy. Pharmacies and healthcare facilities that have the affected medications in stock should stop distribution of them immediately.
For questions regarding the recall, consumers should contact Qualanex by phone at 1-800-505-9291 or by email at firstname.lastname@example.org. Adverse reactions and quality problems associated with the use of these products can be reported to ProPharma at 1-866-901-3784 as well as the FDA's MedWatch program. Consumers should also speak to their healthcare provider about any problems they experience that may be related to the recalled drug products.
Additional details of the recall, including affected lot numbers, are available on the FDA’s website.
Benecard Central Fill has not dispensed products included in this recall.