Microbial Growth Prompts Recall of Two Injectable Drugs

Heritage Pharmaceuticals has initiated a voluntary recall of Amikacin Sulfate Injection, USP, 1g/4mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL) after microbial growth was detected in 1 unreleased sublot of both products.

The recalled Amikacin Sulfate has a lot number of VEAC025 and an expiry date of October 2019. The entire lot was distributed to wholesalers in the US between June 2018 and August 2018.

The recalled Prochlorperazine Edisylate has a lot number of VPCA172 and an expiry date of April 2020. This lot was distributed between October 2018 and November 2018.

Both drugs are manufactured by Emcure Pharmaceuticals and distributed by Heritage. Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. Prochlorperazine Edisylate Injection is indicated to control severe nausea and vomiting and for the treatment of schizophrenia.

At this time, Heritage has not received any reports of adverse events related to this recall. Any adverse reactions should be reported to FDA’s MedWatch program.

For more information contact Qualanex at (800) 505-9291.