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The FDA is notifying the public that Dr. Reddy’s Laboratories Ltd. is voluntarily recalling levetiracetam injection bags due to mislabeling. This recall affects one batch of levetiracetam in 0.54% sodium chloride injection, 1,500 mg/100 mL single-dose infusion bags (NDC 43598-637-52; lot ABD807; expiration date 05/2020), which was distributed between August 14 and September 5, 2018. The label on the external foil pouch accurately indicates the product as levetiracetam in 0.54% sodium chloride injection (1,500 mg/100 mL), but the information printed on the infusion bags is levetiracetam in 0.75% sodium chloride injection (1,000 mg/100 mL). Levetiracetam is an antiepileptic drug labeled as an add-on therapy in patients older than 16 years with myoclonic seizures in patients with juvenile myoclonic epilepsy, partial onset seizures, or primary generalized tonic-clonic seizures.
The company started the recall in October 2018. There have been no reports of adverse events related to this recall to date. Unintentional exposure to the mislabeled product can lead to adverse reactions such as agitation, aggression, coma, depressed level of consciousness, respiratory depression, and somnolence. Contact Inmar (1-800-967-5952) for help returning affected product. Consumers should report any adverse reactions experienced from this product to their provider and the FDA MedWatch Adverse Event Reporting Program online at: www.fda.gov/medwatch/report.htm. Contact Dr. Reddys’s Medical Information Center (1-888-375-3784) with questions about the recall.
Additional Information:
- Company Recall Announcement – February 4, 2019
www.fda.gov/Safety/Recalls/ucm630542.htm