Why it was recalled
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Product description
E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01
Lot numbers, UPCs & expiration codes
Lot # 00538529
Where it was sold
Product was distributed throughout the United States, Hong Kong and New Zealand.
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-0609-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 8, 2018
- FDA report date
- Apr 4, 2018
- Quantity
- 2,136 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bracco Diagnostics Inc.
Original FDA data
Every field from FDA enforcement report D-0609-2018, exactly as published.
Show all FDA fields
- City
- Monroe Township
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79481
- Address
- 259 Prospect Plains Rd Bldg H
- Code information
- Lot # 00538529
- Postal code
- 08831-3820
- Report date
- Apr 4, 2018
- Product type
- Drugs
- Recall number
- D-0609-2018
- Classification
- Class II
- Recalling firm
- Bracco Diagnostics Inc.
- Product quantity
- 2,136 tubes
- Termination date
- Mar 1, 2019
- Reason for recall
- Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01
- Distribution pattern
- Product was distributed throughout the United States, Hong Kong and New Zealand.
- Recall initiation date
- Mar 8, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 29, 2018