Home / Recalls / Genentech, Inc. / D-1175-2017

D-1175-2017 Class I Terminated

Recalled by Genentech, Inc. — South San Francisco, CA

Recall Details

Product Type
Drugs
Report Date
September 27, 2017
Initiation Date
September 5, 2017
Termination Date
January 11, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,882

Product Description

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

Reason for Recall

Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.

Distribution Pattern

Nationwide in the USA

Code Information

Lot# 3128243, 3141239, EXP. 9/30/2018; 3166728, EXP. 2/28/2019.

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  • D-097-2013 Class III — CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count (September 27, 2012)
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  • D-135-2013 Class I — Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL (July 30, 2012)