Class II · Moderate risk
E-Z-Paste Barium Sulfate Esophageal Cream
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Bracco Diagnostics multihance (Gadobenate Dimeglumine)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15
Affected NDC
0270-5164-15
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 |
|---|---|---|---|---|
| MultiHance gadobenate dimeglumine NDC 00270-5164 |
529 mg/mL | Injection, Solution Intravenous |
Bracco Diagnostics INC | Rx |
- Recalling firm
- Bracco Diagnostics Inc
- NDC code
- 0270-5164-15
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1663-2012 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 2012 recalls
Class III · Low risk
VoLumen Barium Sulfate Suspension
Failed Stability Testing: This product is below specification for preservative content.
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
Other failed specification recalls from 2012
All failed specification recalls
Class III · Low risk
Lac-Hydrin
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Class III · Low risk
Lac-Hydrin
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Class II · Moderate risk
VERSAPHARM Ethambutol Tablets
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
Class I · High risk
Carboplatin Injection
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
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