February 28, 2020
American Health Packaging is recalling several lots of desmopressin acetate tablets because product bottles may not contain desiccants, according to the February 26, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were packaged and distributed by American Health Packaging throughout the United States:
- desmopressin acetate tablets, 0.1 mg, 30 tablets (3x10 unit dose blister cards; carton NDC 68084-606-21, unit dose NDC 68084-606-11) from lot 181109 (Exp. 4/30/20); and
- desmopressin acetate tablets, 0.2 mg, 30 tablets (3x10 unit dose blister cards; carton NDC 68084-604-21, unit dose NDC 68084-604-11) from lots 180510 (Exp. 3/31/20) and 181912 (Exp. 4/30/20).
American Health Packaging voluntarily initiated the recall February 7, 2020. On February 18, 2020, the FDA designated the recall Class II. Use of a product under a Class II recall 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, and bleeding disorders.