Heritage Pharmaceuticals issued a voluntary recall of specific lots of amikacin sulfate and prochlorperazine edisylate injections on May 28, 2019, due to possible lack of sterility. Unreleased sublots of both injections tested positive for microbial growth. Use of nonsterile products as sterile injections may result in infection, hospitalization, organ damage, or death. Currently, Heritage has not received any reports of patient harm related to this recall. The affected lots are as follows:
Amikacin sulfate injection 1 gram/4 mL
Lot: VEAC025
Expiry: October 2019
Prochlorperazine edisylate injection 10 mg/2 mL
Lot: VPCA172
Expiry: April 2020
Emcure Pharmacuticals manufactures these injections for Heritage Pharmaceuticals. Amikacin is labeled to treat serious gram-negative infections including Acinetobacter, Escherichia coli, Klebsiella-Enterobacter-Serratia species, Providencia species, some Proteus species, and Pseudomonas species. Heritage distributed Lot VEAC025 between June and August 2018. Prochlorperazine edisylate is labeled for severe nausea and vomiting and for the treatment of schizophrenia, although current schizophrenia treatment guidelines do not recommend prochlorperazine. Heritage distributed Lot VPCA172 between October and November 2018.
Consumers should contact their health care provider if they have experienced any adverse effects while using these medications. Do not stop taking these products without first consulting with a prescriber. Pharmacies and health care facilities should stop dispensing the recalled lots. Call (800-505-9291) or email (recall@qualanex.com) with questions regarding the recall. Report any adverse reactions or quality issues to ProPharma at 866-901-3784. Healthcare professionals and patients are also encouraged to report any side effects involving prescription opioids or other medications to the FDA MedWatch program.
Additional information is available at the following link: