Class II - A situation in which the use of, or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. NONE Class III - A situation in which the use of, or exposure to a violative product is not likely to cause adverse health consequences. Firm-initiated recall ongoing. Microbicide - For Hospital and Professional Use. Firm-initiated recall ongoing.
Firm estimates little to no recalled product remains on the market.
Label bears unapproved indication for ophthalmic use. Distributor, by letter May 2, 1991. Firm-initiated recall ongoing. Product is an unapproved new drug. Lot numbers 1.2.3.5 and 8.9.13.