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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
January 13, 1999

PRODUCT
UDL brand Sucralfate Suspension, 1 g/10 ml, 10 ml unit dose cups. NDC #51079-846-11. Recall #D-057-9.

CODE
Lot numbers: 710032, 710033, 710034, 710052, 711001 & 711002.

MANUFACTURER
Hoechst Marion Roussel (HMR), Kansas City, Missouri (responsible firm).

RECALLED BY
UDL Laboratories, Largo, Florida (repacker), by letter on December 9, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
9,684 cases were distributed.

REASON
Bottle defects and/or glass fragments in the bulk drug.

 

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.