Genentech Recalls Prescription Drug Evrysdi Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Drug Exposure through Eye or Skin Absorption (Recall Alert)

Active Recall Announced March 18, 2021 CPSC #21729

Quick answer

Genentech Recalls Prescription Drug Evrysdi Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Drug Exposure through Eye or Skin Absorption (Recall Alert) is CPSC recall #21729, announced on March 18, 2021. The CPSC cites the following hazard: This recall involves bottles of the prescription drug Evrysdi, a prescription medicine used to treat spinal muscular atrophy (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 remedy is consumers should immediately store evrysdi in a safe location out of reach and sight of children. consumers should inspect the bottle for any leaking. if it is leaking, contact genentech for a free replacement. consumers can continue to use as directed, as the leakage is not anticipated to impact the safety or efficacy of administered medicine. if evrysdi gets on your skin, wash the area with soap and water. if evrysdi gets in your eyes, rinse your eyes with water. genentech is contacting all known purchasers directly.. Affected brand: Genentech, a member of the Roche Group.

Hazard

This recall involves bottles of the prescription drug Evrysdi, a prescription medicine used to treat spinal muscular atrophy (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.

Affected products

Evrysdi™ (risdiplam)

Recalled brands

Genentech, a member of the Roche Group

Remedy

Consumers should immediately store Evrysdi in a safe location out of reach and sight of children. Consumers should inspect the bottle for any leaking. If it is leaking, contact Genentech for a free replacement. Consumers can continue to use as directed, as the leakage is not anticipated to impact the safety or efficacy of administered medicine. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water. Genentech is contacting all known purchasers directly.

Recall date

March 18, 2021

Categories

Evrysdi™ (risdiplam)

Frequently asked questions

What is CPSC recall #21729?

CPSC recall #21729 covers Genentech Recalls Prescription Drug Evrysdi Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Drug Exposure through Eye or Skin Absorption (Recall Alert), announced by the U.S. Consumer Product Safety Commission on March 18, 2021. The CPSC cites the following hazard: This recall involves bottles of the prescription drug Evrysdi, a prescription medicine used to treat spinal muscular atrophy (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.

What is the remedy for recall #21729?

The CPSC remedy for recall #21729 is consumers should immediately store evrysdi in a safe location out of reach and sight of children. consumers should inspect the bottle for any leaking. if it is leaking, contact genentech for a free replacement. consumers can continue to use as directed, as the leakage is not anticipated to impact the safety or efficacy of administered medicine. if evrysdi gets on your skin, wash the area with soap and water. if evrysdi gets in your eyes, rinse your eyes with water. genentech is contacting all known purchasers directly.. Consumers should stop using the product and follow the instructions in the official CPSC notice.

I sell this product on Shopify. What do I need to do?

If you sell Genentech Recalls Prescription Drug Evrysdi Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Drug Exposure through Eye or Skin Absorption (Recall Alert) on Shopify, stop selling the affected units immediately, notify customers who purchased them, and consider whether you have a Section 15(b) reporting obligation to the CPSC. RecallDocket helps Shopify merchants identify affected SKUs and prepare the required safety report.

Where is the official CPSC notice for this recall?

The primary source is the official CPSC notice at https://www.cpsc.gov/Recalls/2021/Genentech-Recalls-Prescription-Drug-Evrysdi-Due-to-Failure-to-Meet-Child-Resistant-Packaging-Requirements-Risk-of-Drug-Exposure-through-Eye-or-Skin-Absorption-Recall-Alert. RecallDocket links to it from this page.

Not legal advice. RecallDocket aggregates publicly available recall information from the U.S. Consumer Product Safety Commission for informational purposes only. For the official notice, remedy instructions, and any safety actions, refer to the CPSC source. Information may be incomplete or out of date.

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