November 10, 2017
AvKare Inc. is recalling 274 cartons of Duloxetine Delayed-release Capsules USP, 20 mg, 50 capsules (NDC 50268-283-15), due to the possibility of slightly elevated levels of phthalic acid in the drugs, according to the November 8, 2017, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects lot 18103, which has a November 2018 expiration. Cartons from the lot were distributed to locations across the United States.
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AvKare Inc. initiated the voluntary recall October 6, 2017. On October 27, 2017, the FDA designated it Class II. The classification suggests use of the affected capsules could cause temporary or reversible adverse effects. The likelihood of serious harm, however, is remote.
The prescription serotonin and norepinephrine reuptake inhibitor (SNRI), Duloxetine Delayed-release Capsules, are indicated for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and chronic musculoskeletal pain.
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