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The recall began in October 2018, was initiated due to a mislabeling on the pre-printed content on the infusion bag for lot ABD807. Thus far, there have been no reported adverse events related to this recall.
Dr. Reddy’s Laboratories has announced that it is continuing its ongoing voluntary recall of continuing its voluntary nationwide recall of lot ABD807 of levetiracetam in 0.54% sodium chloride injection, 1500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in the United States.1
The recall began in October of 2018, was initiated due to a mislabeling complaint which was filed. The pre-printed content on the infusion bag for lot ABD807 was indicative of levetiracetam in 0.75% sodium chloride injection (1500 mg/100 mL). Thus far, however, there have been no reported adverse events related to this recall.
The batch in question was distributed in the United States between August 14, 2018, and September 5, 2018 (NDC 43598-637-52). Dr. Reddy’s stated that it has notified the distributors to arrange for the return of any recalled products.
Wholesalers, distributors, hospitals, and pharmacies with an existing inventory of the lot being recalled are being asked to stop the use and distribution of the product and to quarantine their stock immediately for the return or replacement of all recalled products. As well, those that have further distributed the recalled product are being asked to notify any accounts or additional locations which may have received the recalled product from them.
Dr. Reddy’s noted that instructions for returning product, or additional assistance, can be received by contacting Inmar at 1-800-967-5952 between the hours of 8 AM to 5 PM eastern time, Monday through Friday.
Levetiracetam is available commercially as an oral tablet as Keppra and Keppra XR (UCB Pharma), and Spritam (Aprecia Pharmaceuticals). This injection lot, manufactured by Gland Pharmaceuticals, is indicated in its injection formulation as an adjunct therapy in adults with epilepsy when oral administration is temporarily unfeasible. It is used for patients with partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures.
It was originally approved 20 years ago, in February 1999, under UCB Pharma in 250-mg, 500-mg, and 750-mg tablets. Its approval was based on a trio of phase 3 trials which included more than 900 patients, showing that those treated with it experienced a significant reduction in weekly seizure frequency compared to placebo.2 Since then, levetiracetam was approved as a liquid solution in 2003, and a liquid injection in 2006.
Specifically, in the first study conducted, there were 26.1% and 301.% reductions in weekly partial onset seizures with the 1000 mg/day (n = 97) and 3000 mg/day (n = 101) doses, respectively, compared to no reduction with placebo (n = 95; P <.001 for both) with respective responder rates of 37.1%, 39.6%, and 7.4% (P <.001 for both). Likewise, in the second study, the weekly reductions were 17.1% and 21.4% with the 1000 mg/day (n = 106) and 2000 mg/day (n = 105) doses compared to no reduction with placebo (n = 111; P ≤.001 for both). The responder rates were 20.8% and 35.2% with the lower and higher doses, respectively, compared to 6.3% with placebo (P <.001 for both).3
1. Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling [press release]. Hyderabad, India and Princeton, NJ: Dr. Reddy’s Laboratories; Published February 4, 2019. businesswire.com/news/home/20190203005054/en. Accessed February 4, 2019.
2. First approval for UCB Pharma's Keppra. The Pharma Letter website Published February 12, 1999. thepharmaletter.com/article/first-approval-for-ucb-pharma-s-keppra. Accessed February 4, 2019.
3. Keppra package insert. FDA website. accessdata.fda.gov/drugsatfda_docs/label/2006/021872lbl.pdf. Revised January 2006. Accessed February 4, 2019.