May 2015 FDA Recall Md Gastroview by Mallinckrodt, Inc.
D-1132-2015 - Labeling
This Class II drug recall was voluntarily initiated by Mallinckrodt, Inc. on May 15, 2015 for the product Md Gastroview. The FDA reported the reason for recall as labeling. The product was distributed in Costa Rica and the recall is currently terminated.
Recall Number: D-1132-2015
Labeling: incorrect or missing lot number and/or expiration date
05-15-2015
06-17-2015
6600 bottles
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mallinckrodt, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Costa Rica
07-10-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : B201B, Exp April 2015; B346D, Exp August 2015.
