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FDA Safety Alerts

March 6, 2019

The Food and Drug Administration (FDA) has issued the following safety recalls:

 

Recall: Drospirenone and Ethinyl Estradiol Tablets

The FDA announced that Apotex Corporation is voluntarily recalling 4 lots of drospirenone and ethinyl estradiol tablets due to incorrect tablet arrangements and/or empty blister pockets. Drospirenone and ethinyl estradiol tablets are an estrogen/progestin combination oral contraceptive indicated for the prevention of pregnancy. The recall warns this packaging error could result in a loss of efficacy. Individuals taking drospirenone and ethinyl estradiol tablets should contact their healthcare provider for medical advice and may return the impacted product to their pharmacist. More Information.

 

Recall: Raindrop Near Vision Inlay

RVO 2.0 Inc. (Optics Medical) is recalling the Raindrop Near Vision Inlay due to post-approval study data showing increased risk of corneal haze. The FDA issued this as a Class I recall, as use of these products in patients may result in serious injuries. This recall information is an extension of the safety communication notification released by the FDA in October 2018. The Raindrop Near Vision Inlay is a transparent, curved hydrogel disc that is surgically implanted into the cornea to improve near vision in healthy patients. Raindrop Near Vision Inlays are no longer being distributed in the U.S. More Information.