Customer Service: (262) 538-2900
The following recall is being posted as some veterinarians may use these products in treating their patients.
Updates from a variety of companies using the recalled products
Creative Pet Products and MAI/Genesis (Veterinary Concepts), both of Wisconsin, have recalled thousands of kits because the alcohol prep pads and sterile lubricant jelly could be contaminated with Bacillus cereus bacteria. The kits were distributed in the United States, Australia, the United Kingdom, Taiwan and Costa Rica.
- The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines, Boniva Injection, Fuzeon, Nutropin A.Q. Pen, Pegasys, and TNKase.
- The Triad Group alcohol prep pads are co-packaged and distributed Bayer’s Betaseron.
- Triad® Alcohol Prep Pads are packaged for use with the kit presentation of RELISTOR® (methylnaltrexone bromide) subcutaneous injection. The RELISTOR vial and other components of the kit are not affected by the defective Triad alcohol pad. RELISTOR sold in single vials also is unaffected by this recall.
- Pfizer and Progenics advise patients using the RELISTOR kit not to use the Triad alcohol prep pads included in the RELISTOR packaging for 1 X 7 kits and 1 X 2 starter kits.
- GlaxoSmith Klein advises that some of the alcohol prep pads from Triad may have been included in U.S. packaging for ARIXTRA Starter Kits manufactured by GSK and should not be used.
- Novartis advises that some of the alcohol prep pads from Triad may have been included in packaging for Extavia and should not be used.
- 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.
- Eli Lilly and Company announced that patients should not use the alcohol prep pads made by the Triad Group that are contained in the black starter kits for Forteo® [teriparatide (rDNA origin) injection] in the United States.
Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of Alcohol Prep Pads, Alcohol Swabs or Alcohol Swabsticks manufactured by Triad Group but which are private labeled for many accounts to the consumer level. This recall involves those products marked as STERILE as well as non-sterile products. This recall has been initiated due to concerns from a customer about potential contamination of the products with an objectionable organism, namely Bacillus cereus.
Use of contaminated Alcohol Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients. To date we have received one report of a non-life-threatening skin infection.
Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either “Triad Group,” listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging:
- Cardinal Health
- PSS Select
- Boca/ Ultilet
- Moore Medical
These products were distributed in the United States, Canada and Europe.
Specific customers distributing the product and selling it at the wholesale, hospital and retail pharmacy level have been notified by certified mail with instructions on how to return the product. If a consumer has any of these types of products in their possession listing “Triad Group” as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund or call Triad Group Customer Service Monday through Friday between the hours of 8:30 A.M. and 4:00 P.M. Central Time: 262.538.2900.
DO NOT RETURN THE PRODUCT ON YOUR OWN, simply call the Triad Group Customer Service listed below and we will issue you a return authorization number and make all return arrangements.
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 regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178