Genentech, a member of Swiss drug major Roche Group, is recalling prescription drug Evrysdi or risdiplam as it failed to meet child resistant packaging requirements, according to the U.S. Consumer Product Safety Commission.
The recall involves about 14,000 units of Evrysdi, a prescription medicine used to treat spinal muscular atrophy or SMA in adults and children 2 months of age and older.
The recalled 100 mL amber bottles have “Evrysdi (risdiplam) for oral solution,” the dosage and “NDC 20242-175-07” on the front of the bottle labels.
The products were manufactured in Switzerland and sold at select specialty pharmacies across the United States as a prescribed medicine from August 2020 through the present. The price of the medication varies based on health insurance terms and other factors.
As per the agency, the bottles containing the prescription drug can leak due to a fit issue between the press-in bottle adapter and bottleneck. A leaking bottle holds the risk of drug exposure by contact with skin or eyes. Prescription drugs must be in child resistant packaging that prevents children from gaining access to the contents as required by the Poison Prevention Packaging Act or PPPA.
The recall was initiated after Genentech received 26 reports of leaking bottles. However, the company has not received any reports of injuries to date.
Customers are urged to inspect the bottles for any leaking, and can contact Genentech for a free replacement. However, the consumers can continue to use as directed, as the leakage is not anticipated to impact the safety or efficacy of administered medicine.
In similar recalls citing failure to meet child resistant packaging requirements, Dr. Reddy’s Laboratories, Inc. in February called back about 21,400 blister packages of certain prescription medications. Scalpa Inc. in January called back about 10,000 units of Numb Maximum Strength Topical Anesthetic Cream for the same concerns.
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