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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 25, 1998

PRODUCT
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
#60432-103-15.

Recall #D-104-8.

CODE

Lot numbers: 21387A, 21400A, 21466A, 21466C.

MANUFACTURER

Morton Grove Pharmaceuticals, Inc., Morton Grove,
Illinois.

RECALLED BY

Manufacturer, by letter dated February 24, 1998.
Firm-initiated recall ongoing.

DISTRIBUTION

Indiana, Pennsylvania, California, North
Carolina, Illinois, Florida, Ohio, Tennessee,
Missouri, South Dakota, Utah, Kentucky, New York,
Vermont, North Dakota, Michigan.

QUANTITY

21,500 units were distributed; firm estimated that
25 percent of product remained on market at time
of recall initiation.

REASON

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
dropper.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.