Pain Meds Recalled

Golden State Medical Supply Inc. is recalling 100- and 500-count bottles of 50-mg tramadol hydrochloride tablets because they contain an incorrect package insert. The patient leaflet contains language for 25-mg dosing that requires scored tablets, but the tablets in the bottles are unscored, according to the March 4, 2020, US Food and Drug Administration (FDA) Enforcement Report. 

The recall includes the following products, which were manufactured by Teva Czech Industries and distributed throughout the United States: 

• tramadol hydrochloride tablets, 50 mg, 100-count bottles (NDC 60429-588-01) from lots GS021259 (Exp. 11/31/19); GS021742 and GS022074 (Exp. 2/29/20); GS022619l and GS022836 (Exp. 3/31/20); GS023243 and GS023631 (Exp. 4/30/20); GS023869, GS024562, and GS025492 (Exp. 5/31/20); GS025184 (Exp. 6/30/20); GS026306 (Exp. 9/30/20); GS026654 (Exp. 12/31/20); GS027566 (Exp. 2/28/20); and GS028574 (Exp. 4/30/21); and
• tramadol hydrochloride tablets, 50 mg, 500-count bottles (NDC 60429-588-05) from lots GS021570, GS021444, GS021445, GS021443, GS021447, and GS021446 (11/31/19); GS021745, GS021746, GS021744, GS022076, GS022077, GS022078, GS022075, GS021747, and GS021748 (Exp. 2/29/20); GS022622, GS022623, GS022624, GS022620, GS022837, GS022838, GS022856, and GS022621 (Exp. 3/31/20); GS023029, GS023028, and GS023027 (Exp. 4/30/20); GS023958, GS023959, GS023960, GS025045, GS024929, GS025048, GS025047, GS025588, and GS025046 (Exp. Date 5/31/20); GS025260 and GS025259 (Exp. 6/30/20); GS025717, GS025719, and GS025718 (Exp. 8/31/20); GS023607, GS026308, and GS026309 (Exp. 9/30/20); GS026912, GS026911, and GS026910 (Exp. 12/31/20); GS027678 (Exp. 2/28/21); GS027836 (Exp. 11/30/20); GS027570 and GS027569 (Exp. 2/28/20); and GS027572 and GS027571 (Exp. 4/30/21). 

Golden State Medical Supply voluntarily initiated the recall February 12, 2020. The FDA designated the recall Class III on February 26, 2020. According to the recall classification, use of the affected product is not likely to cause adverse health consequences. 

Tramadol is a narcotic pain medication used to treat moderate to severe pain.

Teva Pharmaceuticals USA recently initiated a similar tramadol recall*, which was announced in the February 26, 2020, US FDA Enforcement Report.

—Jolynn Tumolo

*Read more about Teva’s recall here