Injectable Cancer Drug Recalled Over Particulate Matter

APP Pharmaceuticals, Inc., is issuing a recall of five lots potentially defective <"">Irinotecan Hydrochloride Injection, a medication used for recurrent or progressive metastatic colorectal cancer, the U.S. Food and Drug Administration (FDA) just announced.

APP has voluntarily recalled lots and vials of Irinotecan Hydrochloride Injection:

• Recalled Lots of Irinotecan Hydrochloride Injection: 870DE00301, 870CZ00301, 870DE00101, and 870DE00201

• Recalled vials of Irinotecan Hydrochloride Injection: 100mg/5mL, (20mg/mL), 5mL Single Dose Vial and, 40mg/2mL, (20mg/mL), 2mL Single Dose Vial.

APP said it took this action over an atypical trend in customer complaints concerning lot 870DE00301. Three customers reported that they discovered a particulate in the product solution in lot 870DE00301. Upon further investigation of the returned vials, the particulate was confirmed to be a fungal microbial contaminant. To date, there have been no reports of adverse events related to the recalled products.

APP’s root cause investigation is ongoing; APP’s preliminary investigation indicates that only products from lot 870DE00301 were involved. As a precautionary measure and, in consultation with the U.S. Food and Drug Administration, the lots produced immediately before and after lot 870DE00301 are also being recalled

APP has initiated this voluntary recall of Irinotecan Injection to the retail level over discovery of foreign material and nonsterility in one lot of Irinotecan injection.

Nonsterility of a chemotherapeutic product administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.

The FDA is advising consumers to contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

APP has placed a copy of the Dear Healthcare Professional letter on its Web site, which can be accessed at Customers with product in stock that has a matching lot number to the Recall Notice should follow the directions listed in the Recall Notice.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, or via regular mail or by fax.

• Online:

• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: Mail to address on the pre-addressed form.

• Fax: 1-800-FDA-0178

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