Genentech Recalls Activase Due to Cracked Sterile Water Vials
Genentech is recalling 16,882 units of Activase (alteplase) because the included sterile water vials may have cracked or chipped glass.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 (Severe) according to the rubric.
Plain-English summary
Genentech, Inc. is recalling 16,882 units of Activase (alteplase), 100 mg (58 million IU), Lyophilized vial. The product is packaged with one single-dose 100ml vial of sterile water for Injection USP and one transfer device. The recall affects lots 3128243, 3141239 (expiration 9/30/2018), and 3166728 (expiration 2/28/2019). The product was distributed nationwide in the USA.
The recall was initiated due to a non-sterility issue. Specifically, there is a presence of cracked or chipped glass at the neck of the sterile water for injection vials. This defect poses a risk of contamination or injury if the product is used.
Healthcare providers and patients should stop using the affected lots immediately. Consumers should check their medication packaging for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or contact Genentech for further instructions.
The recalled product
- Product
- Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27
- Manufacturer
- Genentech, Inc.
- Category
- Drug — Injectable Medication
- Affected units
- 16,882
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 (5)
- Lot# 3128243
- 3141239
- EXP. 9/30/2018
- 3166728
- EXP. 2/28/2019.
Distribution
Distributed nationwide across the United States.
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