MD-Gastroview Contrast Solution (Mallinckrodt) – labeling issue (2015)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Mallinckrodt, Inc.
Lot Codes / Batch Numbers
Lot #: B201B, Exp April 2015, B346D, Exp August 2015.
Products Sold
Lot #: B201B, Exp April 2015; B346D, Exp August 2015.
Mallinckrodt, Inc. is recalling MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iod due to Labeling: incorrect or missing lot number and/or expiration date. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: incorrect or missing lot number and/or expiration date
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026