CLASS II Drug recall · Reported 17 Jun 2015 · FDA Enforcement Report
MD-Gastroview (Diatrizoate Meglumine recalled by Mallinckrodt
Mallinckrodt is recalling MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP). The recall was initiated on 15 May 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1132-2015
- FDA event ID
- 71220
- Recalling firm
- Mallinckrodt, Hazelwood, MO
- Brand
- Md Gastroview
- Manufacturer
- Liebel-Flarsheim Company LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 May 2015
- FDA classified
- 10 Jun 2015
- Reported
- 17 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 15 May 2015 | Recall initiated by company | |
| 10 Jun 2015 | Classified by FDA | +26 days |
| 17 Jun 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: incorrect or missing lot number and/or expiration date
Product as listed by the FDA
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
Where it was distributed
Costa Rica
Questions about this recall
Why was it recalled?
Labeling: incorrect or missing lot number and/or expiration date
Which lots are affected?
Lot #: B201B, Exp April 2015; B346D, Exp August 2015.
Where was it sold?
Costa Rica
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mallinckrodt
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | INOmax Dsir -(delivery system) delivers Inomax recalled by Mallinckrodt | Mallinckrodt | Device Malfunction | NJ |
| Drug | CLASS III | Thallous Chloride Tl 201 Injection, Diagnostic Sterile recalled | Mallinckrodt | Packaging Defects | 11 states |
| Drug | CLASS III | Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled | Mallinckrodt | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled | Mallinckrodt | Manufacturing (CGMP) Deviations | Nationwide |
| Device | CLASS II | The Handi-Fil Disposable Syringe Fill Tube is a sterile recalled | Mallinckrodt | Packaging Defects | Nationwide |
Other Diatrizoate Meglumine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gastrografin (Diatrizoate Meglumine recalledGastrografin | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Gastrografin (Diatrizoate Meglumine recalled by Bracco DiagnosticsGastrografin | Bracco Diagnostics | Particulate Matter | Nationwide |