December 30, 2020
Morton Grove Pharmaceuticals Inc. is pulling 127,392 bottles of hydroxyzine hydrochloride oral solution after impurities were detected during routine testing, according to the December 30, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects hydroxyzine hydrochloride oral solution (syrup), 10 mg/5 mL, packaged in:
- 4-ounce (118 mL) bottles (NDC 60432-150-04) from lot UU1328 (Exp. 10/21), and
- 1-pint (473 mL) bottles (NDC 60432-150-16) from lots UU1207 (Exp. 7/21), UU1326 (Exp. 9/21), and UU1327 (Exp. 10/21).
The product was distributed throughout the United States and Puerto Rico.
Morton Grove Pharmaceuticals voluntarily initiated the recall December 9, 2020. The FDA designated the recall Class II on December 23, 2020. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Hydroxyzine hydrochloride syrup is a prescription antihistamine used to relieve anxiety and tension.