Antidepressant Pulled

Jubilant Cadista Pharmaceuticals Inc. is recalling several lots of bupropion hydrochloride extended-release tablets, 150 mg, because samples failed to meet dissolution specifications during routine testing. The recall was included in the March 13, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects 30-count bottles (NDC 59746- 758-30) from lot BR117002C (Exp. 11/19) and 90-count bottles (NDC 59746-758-90) from lots BR117003B and BR117004B (Exp. 11/19). The tablets were distributed to one customer who may have further distributed the product.

Jubilant Cadista Pharmaceuticals voluntarily initiated the recall February 28, 2019. It was designated Class III by the FDA on March 6, 2019, suggesting use of the recalled tablets is not likely to cause harm.

Bupropion is a prescription antidepressant used to treat patients with major depressive disorder and seasonal affective disorder. 

—Jolynn Tumolo