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Synthetic Antibiotic Recall


May 12, 2017

Akorn Inc. is voluntarily recalling 55,968 bottles of grape-flavored sulfamethoxazole and trimethoprim oral suspension, USP 200 mg/40 mg per 5 mL, because of failed dissolution specifications.

Sulfamethoxazole and trimethoprim oral suspension is a prescription synthetic antibacterial combination product.

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According to the May 10, 2017 US Food and Drug Administration (FDA) Enforcement Report, Akorn Inc. initiated the recall March 13, 2017, and the FDA designated it class II May 4, 2017. Class II indicates that while exposure to the product may cause temporary or medically reversible adverse health consequences, they are unlikely to be serious.

Affected lots of the 16 fluid-ounce (473 mL) bottles include 348913 (Exp. 1/18), 349552 (Exp. 3/18), 349681 (Exp. 3/18), 349683 (Exp. 3/18), 349685 (Exp. 3/18), 349687 (Exp. 3/18), 349689 (Exp. 3/18), and 350636 (Exp. 3/18).

The impacted bottles were distributed throughout the United States.

Jolynn Tumolo

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