Drug recall: Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic…

Class I FDA enforcement event 63258. Recall start date: 30 Jul 2012. Status in the FDA record: Terminated. Termination date: 25 Mar 2013.

Reason for recall, in the words of FDA

Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.

Class I, in the words of FDA

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

Genentech Inc started this drug recall on 30 Jul 2012. The firm address in the FDA record is in South San Francisco, CA. FDA put the recall in Class I. FDA event 63258 has 1 product record. The first FDA enforcement report date is 30 Jan 2013. The record gives the status Terminated, with the termination date 25 Mar 2013.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide

Recalling firm

Genentech Inc, South San Francisco, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 63258: product records
Recall number	Product	Quantity	Class	Status	Report date
D-135-2013	Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit;…	2,140 kits	Class I	Terminated	30 Jan 2013

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Drug events that started in 2012: 209
Share of these events in Class I: 15%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 10

Other events of the firm

Other FDA enforcement events of Genentech Inc
Initiated	Product (first record)	Type	Class	Records
20 May 2024	Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64	Drug	Class II	1
18 Oct 2022	Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Su	Drug	Class III	1
9 Jun 2021	Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Sy	Drug	Class II	1
20 Apr 2021	Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distribut	Drug	Class III	1
5 Feb 2018	Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Mem	Drug	Class III	1
5 Sep 2017	Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water	Drug	Class I	1
13 Mar 2017	Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc.	Drug	Class II	1
27 Sep 2012	CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b	Drug	Class III	1
20 Sep 2012	Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#5024	Drug	Class II	2

Genentech Inc: all 10 events

Official channels

FDA enforcement report D-135-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 63258. https://recallregister.com/fda/i/63258/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide
What quantity of product is in FDA event 63258?: The FDA record gives this quantity: 2,140 kits
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2012 have the same class?: 15% of the 209 drug events that started in 2012 are in Class I.