Antidepressant Capsules Recalled Over Impurity
Amerisource Health Services LLC is recalling nearly 70 000 bottles of duloxetine delayed-release capsules because of an N-nitroso duloxetine impurity, according to the December 11, 2024, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were manufactured by Aurobindo Pharma Limited, Hyderabad, India, for BluePoint Laboratories:
- duloxetine delayed-release capsules, 20 mg, 60-count bottles (NDC 68001-413-06), from lots DT2023001A and DT2023009A (Exp. 1/31/25);
- duloxetine delayed-release capsules, 30 mg, 30-count bottles (NDC 68001-414-04), from lots DT3023019B and DT3023020A (Exp. 1/31/25);
- duloxetine delayed-release capsules, 30 mg, 1000-count bottles (NDC 68001-414-08), from lot DTB23098A (Exp. 8/31/25);
- duloxetine delayed-release capsules, 60 mg, 1000-count bottles (NDC 68001-415-08), from lots DT6022159A, DT6022167A, and DT6022168A (Exp. 11/30/24); DT6023034A (Exp. 12/31/24); DT6023050A, DT6023051A, DT6023063A, and DT6023067A (Exp. 1/31/25); and DT6023073A and DT6023072A (Exp. 2/28/25).
The affected capsules were distributed in Pennsylvania, Ohio, and Puerto Rico.
Amerisource Health Services initiated the recalls on November 14, 2024. The FDA designated them Class II on December 3, 2024. Per the recall classification, the use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Duloxetine is a serotonin and norepinephrine reuptake inhibitor with indications for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain.
