Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Reported: June 5, 2024 Initiated: May 20, 2024 #D-0509-2024
Product Description
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Reason for Recall
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Details
- Recalling Firm
- Genentech, Inc.
- Units Affected
- Lot:3618858 = 105,759; Lot:3618873 =90,359
- Distribution
- Nationwide within the United States
- Location
- South San Francisco, CA
Frequently Asked Questions
What product was recalled? ▼
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64. Recalled by Genentech, Inc.. Units affected: Lot:3618858 = 105,759; Lot:3618873 =90,359.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 5, 2024. Severity: Moderate. Recall number: D-0509-2024.
Related Recalls
FDA Drug Moderate
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: U…
Unichem Pharmaceuticals USA Inc. · 2026-02-11
FDA Drug Critical
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San…
Green Lumber Holdings, LLC · 2026-02-11
FDA Drug Moderate
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500…
Granules Pharmaceuticals Inc. · 2026-02-11
FDA Drug Critical
Diclofenac Sodium, Topical Gel, 3%, 100 g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1…
SUN PHARMACEUTICAL INDUSTRIES INC · 2026-02-11
FDA Drug Critical
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
HANDELNINE GLOBAL LLC · 2026-02-11