September 20, 2017
Degasa SA de CV, Mexico, is voluntarily recalling 1-gallon bottles of over-the-counter povidone iodine, USP, prep solution, 10%, according to the September 13, 2017, US Food and Drug Administration (FDA) Enforcement Report. The topical antiseptic was manufactured for PSS World Medical Inc.
A labeling mistake prompted the recall. Although labeled povidone iodine 10%, the bottles contain povidone iodine 7.5%. The outer box, however, is labeled correctly.
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The recall includes 720 bottles from lot 3A176011, which has an October 2018 expiration date. The bottles were distributed in California and Illinois.
Degasa SA de CV announced the recall August 4, 2017. The FDA designated it Class II September 7, 2017, indicating use of the affected solution could cause temporary or reversible adverse effects. The probability of serious harm, though, is remote.