February 14, 2020
Teva Pharmaceuticals USA is recalling several lots of desmopressin acetate tablets over concerns product bottles may not contain desiccants. The recall is included in the February 12, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products:
- desmopressin acetate tablets, 0.1 mg, 100-count bottles (NDC 0591-2464-01) from lots 1281203M (Exp. 3/20) and 1290113M (Exp. 4/20); and
- desmopressin acetate tablets, 0.2 mg, 100-count bottles (NDC 0591-2465-01) from lots 1269726M (Exp. 1/20), 1283269M (Exp. 3/20), 1283270M (Exp. 3/20), 1292992M (Exp. 4/20), and 1292993A (Exp. 4/20).
The tablets were manufactured by Actavis Laboratories and distributed within the United States by Actavis Pharma.
Teva Pharmaceuticals voluntarily initiated the recall January 27, 2020. The FDA designated the recall Class II on February 6, 2020. Use of a product under a Class II recalls could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Desmopressin is a prescription clotting promotor and antidiuretic used to treat patients with diabetes insipidus, bedwetting problems, or bleeding disorders.