Watson Pharmaceuticals, Inc. Announces Recall of Alcohol Prep Pads

Potential bacterial contamination prompts recall

/ Author:  / Reviewed by: Joseph V. Madia, MD

Watson Pharmaceuticals, Inc. has announced the market recall of alcohol prep pads manufactured by Triad Group.

The pads make up a component of a convenience kit that is distributed with other products. Triad Group is recalling the alcohol prep pads packaged with products, including Watson’s Trelstar® (triptorelin pamoate for injectable suspension) product, due to potential contamination of the pads with the bacteria, Bacillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.

The Company emphasized that there is no potential contamination of the Trelstar product, the MIXJECT® system or components in the Trelstar packaging, other than the Triad alcohol prep pad. The Trelstar drug and the MIXJECT® system have not been affected in any way.

Watson has ceased shipments of Trelstar packaging components that incorporate the Triad alcohol pad while it pursues options to remove or replace the prep pad. Convenience kits will not be available in Trelstar commercial packages until new convenience kits incorporating a replacement alcohol prep pad are available for distribution in March 2011. The Company also noted that it was cooperating fully with the FDA, and notifying its customers.

Watson instructs customers to immediately discontinue the use of the Triad alcohol prep pad included in the Trelstar convenience kit and to appropriately dispose of the entire convenience kit. The Company also recommends customers use an alternative alcohol prep pad product that is not involved with this recall, or to use a sterile gauze pad in conjunction with isopropyl alcohol as an alternative. Both prep pads and gauze should be available at your local pharmacy.

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Review Date: 
February 8, 2011