Herceptin Vials to Be Checked for Damage, FDA Warns

July 14, 2008 — An increased number of complaints have been received regarding damaged and broken vials of trastuzumab injection 440 mg (Herceptin, Genentech, Inc) and bacteriostatic water for injection (BWFI) diluent, the US Food and Drug Administration (FDA) has warned clinicians. Affected vials (NDC 50242-0134-68; List 15534) were shipped from mid-2007 to the present.

The damage may lead to loss of product sterility and a risk for patient infection, according to an alert sent by MedWatch, the FDA's safety information and adverse event reporting program.

"A survey of the company's adverse event surveillance systems did not indicate evidence of a change in the safety profile of Herceptin as a result of this vial damage," the company noted in a letter to healthcare professionals, adding that the risk to patients is considered negligible because of a low occurrence rate and the obviousness of affected vials. No manufacturing errors have been identified.

Clinicians are advised to examine cartons of trastuzumab and BWFI vials for moisture, which may also be present on vial surfaces. Individual vials should be inspected for cracks and other damage before use, and the presence of a vacuum should be verified during reconstitution, as demonstrated by automatic depression of the syringe plunger on piercing the rubber stopper.

Compromised vials should be returned unused to the manufacturer. Product return and credit may be arranged by contacting the company at 1-800-334-0290.

Trastuzumab intravenous infusion is indicated for the treatment of breast cancer.

Adverse events related to use of trastuzumab injection and diluent should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Cite this: Yael Waknine. Herceptin Vials to Be Checked for Damage, FDA Warns - Medscape - Jul 14, 2008.

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