The voluntary recall was issued by K.C. Pharmaceuticals, Inc due to “a lack of assurance of sterility” for the drops, according to the FDA notice, meaning the company cannot guarantee the products are safe from bacterial contamination.
The California-based pharmaceutical company voluntarily issued the recall.
The first notice was issued on March 3, but the recall was bumped to a Class II warning on Tuesday.
A Class II recall consists of “a situation in which 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,” according to the FDA.
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