Class III · Low risk
VoLumen Barium Sulfate Suspension
Failed Stability Testing: This product is below specification for preservative content.
E-Z-Paste Barium Sulfate Esophageal Cream
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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
Affected NDC
32909-0770-01
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| E-Z-Paste Barium Sulfate NDC 32909-0770 |
.6 g/g | Cream Oral |
E-Z-EM Canada Inc | Rx |
- Recalling firm
- Bracco Diagnostics Inc.
- NDC code
- 32909-770-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0609-2018 · 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 recalls by Bracco Diagnostics Inc.
All 2018 recalls
Class III · Low risk
Tagitol V Barium Sulfate Suspension
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Class II · Moderate risk
Gastrografin
Presence of foreign substance: One lot of the product may contain black foreign particles
Class II · Moderate risk
Cardiogen-82
GMP deviation; Sr-82 levels exceeded alert limit specification
Other stability / shelf life recalls from 2018
All stability / shelf life recalls
Class III · Low risk
COSOPT Ophthalmic Solution
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Class II · Moderate risk
INFed (Iron Dextran Injection USP)
Failed Stability Specification: out of specification for iron content.
Class III · Low risk
Megestrol Acetate Oral Suspension
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Class II · Moderate risk
Nystatin and Triamcinolone Acetonide Cream
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
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