Why it was recalled
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.
Product description
OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10
Lot numbers, UPCs & expiration codes
Lot #'s D01894E and D01894G
Where it was sold
USA, Italy and France
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-0828-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 13, 2018
- FDA report date
- May 16, 2018
- Quantity
- 8509 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Septodont Inc.
Original FDA data
Every field from FDA enforcement report D-0828-2018, exactly as published.
Show all FDA fields
- City
- Louisville
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 79976
- Address
- 416 S Taylor Ave
- Code information
- Lot #'s D01894E and D01894G
- Postal code
- 80027-3028
- Report date
- May 16, 2018
- Product type
- Drugs
- Recall number
- D-0828-2018
- Classification
- Class III
- Recalling firm
- Septodont Inc.
- Product quantity
- 8509 boxes
- Termination date
- Dec 14, 2020
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10
- Distribution pattern
- USA, Italy and France
- Recall initiation date
- Apr 13, 2018
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 22, 2018