Drug Safety Alerts

Amikacin Sulfate Injection, USP, 1g/4 mL and Prochlorperazine Edisylate Injection, USP, 10mg/2mL - Consumer-level Recall

05/28/2019

On May 28, 2019, the United States Food and Drug Administration (FDA) issued a consumer-level recall of Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL) manufactured by Emcure Pharmaceuticals Ltd. (“Emcure”) and distributed by Heritage Pharmaceuticals, Inc. This recall was issued due to microbial growth having been detected in one unreleased sublot of Lot VPCA172 and one unreleased sublot Lot VEAC025, which may indicate a lack of sterility in the other sublots.

A complete list of the affected products and lot numbers is provided here.

Non-sterile injectable products that are intended to be sterile may result in a site-specific or systemic infection, which in turn may cause hospitalization, organ damage or death. To date, Heritage has not received adverse event reports related to this event.

Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter (Mima-Herellea) species.

Prochlorperazine Edisylate Injection is indicated to control severe nausea and vomiting and for the treatment of schizophrenia. Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.

CVS Caremark Response: Because of this action, CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL) or Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL) to contact their prescriber.

For more information about the recall, please call Heritage Pharmaceuticals Inc. c/o Qualanex, LLC toll-free at 1‑800-505-9291 or recall@qualanex.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.