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Class II: temporary or reversible health riskTerminated

Mallinckrodt MD-Gastroview Recall

MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP)

Mallinckrodt, Inc. · Hazelwood, MO

Risk level
Class II
Reported by FDA
Jun 17, 2015
Recall ID
D-1132-2015
Check your lot numberHow we source this data

Summary

Mallinckrodt recalled MD-Gastroview starting May 15, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1132-2015 on Jun 17, 2015. Reason: Labeling: incorrect or missing lot number and/or expiration date. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Costa Rica

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1132-2015
Classification
Class II
Status
Terminated
Recall initiated
May 15, 2015
FDA report date
Jun 17, 2015
Quantity
6600 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Mallinckrodt, Inc.

Original FDA data

Every field from FDA enforcement report D-1132-2015, exactly as published.

Show all FDA fields
City
Hazelwood
State
MO
Status
Terminated
Country
United States
Event ID
71220
Address
675 James S McDonnell Blvd
Code information
Lot #: B201B, Exp April 2015; B346D, Exp August 2015.
Postal code
63042-2301
Report date
Jun 17, 2015
Product type
Drugs
Recall number
D-1132-2015
Classification
Class II
Recalling firm
Mallinckrodt, Inc.
Product quantity
6600 bottles
Termination date
Jul 10, 2017
Reason for recall
Labeling: incorrect or missing lot number and/or expiration date
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Costa Rica
Recall initiation date
May 15, 2015
Initial firm notification
Letter
Center classification date
Jun 10, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1132-2015, published Jun 17, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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