Md Gastroview Solution
FDA Recall NDC 0019-4816
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Md Gastroview (NDC 0019-4816). A significant event, classified as Class II, was initiated on May 15, 2015 by Liebel-flarsheim Company Llc. The reported reason for this action was: "Labeling: incorrect or missing lot number and/or expiration date"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling: incorrect or missing lot number and/or expiration date
May 15, 2015
Jun 17, 2015
6600 bottles
Recall Profile & Regulatory Data
Event ID
71220
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mallinckrodt, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Costa Rica
Termination Date
Jul 10, 2017
Product Description
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.
Affected Packages Involved in this Recall
0019-4816-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
