|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
March 25, 1998
MGP Hyoscyamine Oral Drops, hyoscyamine sulfate
0.125 mg/mL; Rx oral liquid used as adjunctive
therapy in the treatment of peptic ulcers,
treatment of infant colic, et al. packaged in
15 mL bottle with 0.25 mL dropper. NDC
Lot numbers: 21387A, 21400A, 21466A, 21466C.
Morton Grove Pharmaceuticals, Inc., Morton Grove,
Manufacturer, by letter dated February 24, 1998.
Firm-initiated recall ongoing.
Indiana, Pennsylvania, California, North
Carolina, Illinois, Florida, Ohio, Tennessee,
Missouri, South Dakota, Utah, Kentucky, New York,
Vermont, North Dakota, Michigan.
21,500 units were distributed; firm estimated that
25 percent of product remained on market at time
of recall initiation.
Mislabeling - Labeling indicates each dropperful
contains 0.125 mg drug based on a 1 mL dropper,
however these lots are packaged with 0.25 mL