December 15, 2020

Morton Grove Pharmaceuticals has issued a voluntary recall of four batches of Hydroxyzine Hydrochloride (HCl) Oral Solution, USP (Syrup), 10mg/5mL due to an impurity. Investigation is ongoing. However, a Health Hazard Assessment has been completed and concluded that there is no evidence of a reasonable probability of serious adverse health consequences due to the impurity.

Hydroxyzine HCl is an antihistamine that is indicated for use a sedative and to treat anxiety and certain allergic responses. As of the date of the recall, Morton Grove has not received any reports of adverse events related to the affected product. The affected batches are:

Batch Number Expiration Date
UU1207 July 2021

 

Batch Number Expiration Date
UU1326

UU1327

UU1328

September 2021

October 2021

October 2021

Patients who have questions regarding the recalled product should contact their pharmacist and/or prescriber. Adverse events that may be related to use of the drug should be reported to a healthcare provider and can also be reported to the U.S. FDA’s MedWatch program.

There is minimal member impact through Benecard Central Fill.

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