Why it was recalled
Presence of foreign substance: One lot of the product may contain black foreign particles
Product description
Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40
Lot numbers, UPCs & expiration codes
Lot # 00500512, Exp. 11/15
Where it was sold
Nationwide
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-885-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 21, 2013
- FDA report date
- Aug 21, 2013
- Quantity
- 29,436 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bracco Diagnostics Inc
Original FDA data
Every field from FDA enforcement report D-885-2013, exactly as published.
Show all FDA fields
- City
- Monroe Township
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 65878
- Address
- 259 Prospect Plains Rd.
- Address (line 2)
- Building H
- Code information
- Lot # 00500512, Exp. 11/15
- Postal code
- 08831
- Report date
- Aug 21, 2013
- Product type
- Drugs
- Recall number
- D-885-2013
- Classification
- Class II
- Recalling firm
- Bracco Diagnostics Inc
- Product quantity
- 29,436 bottles
- Termination date
- Jan 23, 2015
- Reason for recall
- Presence of foreign substance: One lot of the product may contain black foreign particles
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 21, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 12, 2013