Class II · Moderate risk
OraVerse
Defective container: cracked/broken cartridges
National Drug Code
Is NDC 0362-0101-10 recalled?
Oraverse · 10 CARTRIDGE in 1 CARTON (0362-0101-10) / 1.7 mL in 1 CARTRIDGE
Yes — this exact package was recalled
2 FDA recalls name the code 0362-0101-10 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
1 of these recalls is still ongoing.
- Active ingredient
- Phentolamine Mesylate
- Strength
- PHENTOLAMINE MESYLATE .235 mg/mL
- Form
- Injection, Solution · Submucosal
- Labeler
- Septodont, Inc.
- Type
- Human Prescription Drug
- Product code
- 0362-0101
Recalls naming this package
Class III · Low risk
OraVerse (Phentolamine Mesylate)
Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
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