Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo sing...

FDA Drug Recall #D-0025-2023 — Class III — October 18, 2022

Recall Summary

Recall Number D-0025-2023
Classification Class III — Low risk
Date Initiated October 18, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Genentech Inc
Location South San Francisco, CA
Product Type Drugs
Quantity 452 vials and implants

Product Description

Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990.

Reason for Recall

Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.

Distribution Pattern

Nationwide in the USA

Lot / Code Information

Lot/Exp: a) 3499188, Exp 10/31/2022; Lot 3523071, Exp 6/30/2023; b) 3456735, Exp 10/23/2026; 3456737; Exp 10/29/2026; 3477671, Exp 10/31/2026; 3480781, Exp 12/19/2026; 3506526, Exp 02/25/2027; 3506531, Exp 04/15/2027

Other Recalls from Genentech Inc

Recall # Classification Product Date
D-0650-2021 Class II Xolair (omalizumab) Injection, 150 mg/1 mL, 1 p... Jun 9, 2021
D-0357-2021 Class III Evrysdi (risdiplam) for oral solution, 60 mg/80... Apr 20, 2021
D-087-2013 Class II Nutropin AQ NuSpin 20 (somatropin (rDNA origin)... Sep 20, 2012
D-088-2013 Class II Nutropin AQ NuSpin 10 (somatropin (rDNA origin)... Sep 20, 2012
D-135-2013 Class I Trastuzumab Kit containing 1 vial Trastuzumab (... Jul 30, 2012

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.