A Class I recall has been issued for potentially contaminated ultrasound gel, the U.S. Food & Drug Administration (FDA) just announced. A Class I recall involves a situation in which there exists a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Pharmaceutical Innovations, Inc.’s Other-Sonic Generic Ultrasound Transmission Gel is being recalled due to potential microbial contamination that included organisms such as Pseudomonas aeruginosa and Klebsiella oxytoca.
This case involves Pharmaceutical Innovations, Inc.’s Other-Sonic Generic Ultrasound Transmission Gel lots sold in 250 milliliter (mL) bottles and 5 liter (l) dispensing containers and include lot numbers 060111, 080111, 090111, and 100811.
Lot 120111 should also not be used, said the FDA, which noted that this lot, although not being voluntarily recalled by Pharmaceutical Innovations, Inc., was found to also contain the pathogens Pseudomonas aeruginosa and Klebsiella oxytoca in FDA testing.
The recalled products’ manufacturing dates are from June 2011 through December 2011 and the recalling firm, Pharmaceutical Innovations Inc. is located at 897 Frelinghuysen Avenue, Newark, New Jersey, 07114. The firm can be reached, by telephone, at 1.973.242.2900.
Other-Sonic Generic Ultrasound Transmission Gel is a non-sterile gel utilized in ultrasound procedures for the purpose of improving the transmission and receipt of ultrasound waves. Although this product is not labeled as either sterile or non-sterile, it is NOT sterile.
Pharmaceutical Innovations, Inc sent an Urgent Message Notice letter dated March 2, 2012 with a follow-up letter dated March 9, 2012 and an Inventory Withdrawal letter dated March 23, 2012 by email and fax to all affected customers. Customers were instructed to examine their inventory, stop distributing this product, and return all remaining inventory for a replacement.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, by telephone, or by FAX. Information on this program is available at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm