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Recall Observatory FDA recall evidence

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

D-1132-2015

May 15, 2015

Class II

Product summary

Firm
Mallinckrodt, Inc.
Event
Event 71220
Status
Terminated
Classification
Class II
Quantity
6600 bottles
Official record key
drug-enforcement:D-1132-2015

Official wording

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

Code information: Lot #: B201B, Exp April 2015; B346D, Exp August 2015.

Distribution pattern: Costa Rica

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: incorrect or missing