Genentech recalls
FDA enforcement reports naming Genentech Inc as the recalling firm.
- Recall reports
- 11
- Class I (serious)
- 2
- Most recent report
- Jun 5, 2024
- Jun 5, 2024Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech IncDrug · Genentech, Inc.Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.Class II
- Nov 9, 2022Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Su…Drug · Genentech IncDefective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.Class III
- Jul 14, 2021Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutane…Drug · Genentech IncFailed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.Class II
- May 5, 2021Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0Drug · Genentech IncDefective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.Class III
- Feb 21, 2018Klonopin (clonazepam) 0Drug · Genentech, Inc.Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.Class III
- Sep 27, 2017Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-…Drug · Genentech, Inc.Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.Class I
- Apr 12, 2017Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in SwitzerlandDrug · Genentech Inc.Superpotent Drug: An oversized tablet was found in a bottle.Class II
- Jan 30, 2013Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg)Drug · Genentech IncPresence 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
- Dec 26, 2012CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottle…Drug · Genentech, Inc.Short Fill: some bottles contained less than 120-count per labeled claim.Class III
- Dec 12, 2012Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South…Drug · Genentech IncMiscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).Class II
- Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South…
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