Class III · Low risk
MD-Gastroview
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: incorrect or missing lot number and/or expiration date
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDC
0019-4816-04
Compare with the code on your package — it is the most precise check available.
Drug: Iodine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Md Gastroview diatrizoate meglumine and diatrizoate sodium NDC 00019-4816 |
DIATRIZOATE MEGLUMINE 600 mg/mL; DIATRIZOATE SODIUM 100 mg/mL | Solution Oral|rectal |
Liebel-Flarsheim Company LLC | Rx |
- Recalling firm
- Mallinckrodt, Inc.
- NDC code
- 0019-4816-04
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1132-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Iodine recalls
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Class II · Moderate risk
BD PurPrep
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Class II · Moderate risk
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Class II · Moderate risk
BD PurPrep
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Other recalls by Mallinckrodt, Inc.
All 2015 recalls
Class III · Low risk
Thallous Chloride Tl 201 Injection
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
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