Trastuzumab Kit containing 1 vial Trastuzumab recall: Particulate Matter
Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1%…
Why was Trastuzumab Kit containing 1 vial Trastuzumab recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 454138, Exp 07/14 (containing Trastuzumab Lot #: 886618, Exp 12/14; and Bacteriostatic Water for Injection, USP Lot #: 08-368-DK-01, Exp 07/14)
- Product
- Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1%…
- Recalling firm
- Genentech Inc
- Quantity
- 2,140 kits
- Distribution
- Nationwide
- Recall date
- January 30, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)