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Executive Summary

FISONS CLASS RECALL OF OPTICROM PRESCRIPTION EYE DROPS involves over 45,000 bottles from two lots of the 4% ophthalmic solution 10 ml bottles, the company announced in a July 13 press release. Evidence of bacterial contamination that could cause serious eye infections in scratched or damaged eyes was found in the two lots of the cromolyn sodium product. The two lots of Opticrom under recall are KF35V, of which 45,223 bottles were distributed, and KF7A, of which 114 bottles were distributed. The recall extends to the consumer level. Distribution was nationwide and included Puerto Rico. The contamination was discovered following tests by Fisons, which manufactures the product in the U.K. The tests "indicated the possible presence of Bacillus cereus in lot KF7A and an unidentified anaerobic bacillus in lot KF35V," the release states. Opticrom is indicated for certain eye allergies, with recommended dosing of one-to-two drops four-to-six times a day. A same-day FDA press release warns that "if patients have a slight scratch on the eye, they are at high risk of developing a potentially sight-threatening infection from a contaminated eye solution."

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