Cathflo Activase Injection Vials Recalled Due to Deformed Stoppers
Genentech is recalling Cathflo Activase injection vials in two lots due to deformed stoppers found during manufacturing that compromise sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves an intravenous pharmaceutical product where deformed stoppers compromise sterility assurance, classified as FDA Class II. It qualifies as High severity under the criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Genentech, Inc. is recalling Cathflo Activase (alteplase) 2 mg injection vials from two specific lots distributed nationwide within the United States. The affected lots are Lot 3618858 (containing approximately 105,759 units) and Lot 3618873 (containing approximately 90,359 units), both with an expiration date of January 31, 2026.
The recall was initiated due to deformed stoppers observed during filling operations. The deformed stoppers compromise the assurance of sterility required for this intravenous medication.
Healthcare providers and facilities should check their inventory for vials from the affected lots and quarantine any units identified. For additional information regarding returns and replacement product, contact Genentech, Inc.
The recalled product
- Product
- CATHFLO ACTIVASE (ALTEPLASE)
- Brand
- CATHFLO ACTIVASE
- Manufacturer
- Genentech, Inc.
- Category
- Drug — Intravenous Injectable
- Hazard
- sterility-failure
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 3618858
- 3618873
- Exp. Date 01/31/2026
Distribution
Distributed nationwide across the United States.
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