FDA recall D-1132-2015

Mallinckrodt, Inc. · Class II · drug

Product

MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iodine For Gastrointestinal Radiography; Oral or rectal use only; Rx only; 30 mL; Single-Unit Container; ; Mallinckrodt Inc., St. Louis, MO 63042. NDC 0019-4816-04

Reason for recall

Labeling: incorrect or missing lot number and/or expiration date

Distribution

Costa Rica

Key facts

Status
Terminated
Initiation date
2015-05-15
Report date
2015-06-17
Termination date
2017-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hazelwood, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1132-2015