Levetiracetam

Multiple drugmakers have had to yank their products in the U.S. this year over manufacturing and quality concerns. A trio of drugmakers have issued separate recalls in the U.S. thanks to string of production flubs, including failed impurity and dissolution specifications and incorrect labelling of infusion bags.The companies behind the product pulls are Dr. Reddy’s Laboratories, Sun Pharma and Zydus Pharmaceuticals, all three of which hail from India. The drugmakers are recalling seizure treatments, painkillers and a chemotherapy drug, respectively, according to the FDA’s online enforcement report, which the regulator uses to catalogue recalls. In the case of Dr. Reddy’s, the company unveiled a voluntary recall on March 13 for one lot of 1,000 mg/100 ml single-dose levetiracetam infusion bags that had been shipped out across the U.S. in early November.  The infusion bags from the suspect batch were incorrectly labeled as 500 mg/100 ml levetiracetam in 0.82% sodium chloride injection, while the aluminum overwrap packaging correctly identifies the product as levetiracetam in 0.75% sodium chloride injection 1,000 mg/100 ml, Dr. Reddy’s explained in its recall notice.Levetiracetam is typically used to treat certain types of seizures when patients are unable to take an oral medication. Although Dr. Reddy’s says there have so far been no reported safety events related to the product pull, patients receiving higher-than-expected doses of the drug by rapid intravenous infusion are at risk of “immediate and serious side effects,” including liver injury, respiratory depression and coma, the company explained. Sun Pharma, for its part, is recalling nearly 10,000 100 mg bottles of morphine sulfate extended-release tablets after the products failed to meet FDA dissolution specifications. The painkillers are part of lot AD16615, which was set to expire in July. The morphine sulfate tablets at issue were distributed nationwide, according to the FDA’s enforcement report.Sun initiated the Class II recall on Feb. 6. The tablets were manufactured by the Indian drugmaker’s subsidiary Ohm Laboratories in New Brunswick, New Jersey.Lastly, Zydus Pharmaceuticals initiated two separate Class II recalls on Feb. 13 covering a whopping 38,871 vials of the chemotherapy injection nelarabine, which were manufactured at the company’s Ahmedabad, India, production facility.The drugmaker issued the recall due to failed impurity and degradation specifications, the FDA’s enforcement report notes.The far-reaching product pull accounts for more than 20 lots of the chemotherapy med, which were set to expire as early as last month or as late as July 2026, depending on the specific batch. Multiple drugmakers have had to yank their products in the U.S. this year, with one recent recall yielding significant interest for its scope and treatment type.Earlier this month, Glenmark Pharma revealed it was recalling some 1.48 million bottles of the generic attention-deficit/hyperactivity disorder (ADHD) drug atomoxetine after detecting unacceptable levels of a possible carcinogen in the product.Atomoxetine—previously sold by Eli Lilly under the brand name Strattera—is a selective norepinephrine reuptake inhibitor (sNRI) independent of the stimulant-based offerings that make up the bulk of ADHD treatment.

HYDERABAD, India--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level, in the United States. The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL. Risk Statement: Patients who are administered the mislabeled product will likely experience adverse events. Because the infusion bag is labelled as 500 mg/100 mL but actually contains 1,000 mg/100 mL dose, the patient could receive double the dose of intravenous levetiracetam than intended which could lead to immediate and serious side effects including hypersensitivity reactions, liver injury, hematological toxicity, somnolence, fatigue, dizziness, coordination difficulties, agitation, aggression, depressed level of consciousness, respiratory depression, and coma. Patients receiving high doses of levetiracetam by rapid intravenous infusion for the treatment of status epilepticus would be most at risk for severe adverse events. Dr. Reddy’s has not received any reports of adverse events related to this recall. Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) and Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg/100 mL (5mg/mL) are both indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible: - Partial onset seizures - Myoclonic seizures in patients with juvenile myoclonic epilepsy - Primary generalized tonic-clonic seizures Each product is packaged in single-dose infusion bags with an aluminum overwrap, 10 single-dose bags packed in a carton. Identification information such as lot number, expiration date and NDC is presented in the table below. The batch was distributed nationwide between November 4, 2024, and November 6, 2024, to wholesalers. DESCRIPTION OF MISLABELLED BAGS BEING RECALLED: NDC Number Product Overwrap Description Product Infusion Bag Primary Description Lot Number Expiration Date 43598-635-52 Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag. A1540076 08/2026 43598-636-52 Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL single-dose bag A1540076 08/2026 DESCRIPTION OF CARTON BEING RECALLED: NDC Number Carton Description Lot Number Expiration Date 43598-636-10 Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL 10 Single-Dose Bags A1540076 08/2026 Dr. Reddy’s Laboratories, Inc is notifying its distributors and customers to arrange for return of any recalled product. Wholesalers, distributors, hospitals, and pharmacies with an existing inventory of the lot being recalled should stop use and distribution and quarantine the product immediately for return/replacement of all recalled products. Wholesalers, distributors, and pharmacies that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them. For instructions on returning product or additional assistance, call Inmar at 1-877-645-1584 between the hours of 9 a.m. to 5 p.m. ET, Monday through Friday. Consumers with questions regarding this recall can contact Dr. Reddy’s Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 8 p.m. ET, Monday through Friday. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality concerns experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report online at www.fda.gov/medwatch/report.htm . Regular Mail or Fax: Download form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being executed with the knowledge of the U.S. Food and Drug Administration. RDY-0325-782 About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com. 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