OraVerse Phentolamine Injection Recalled for Defective Cartridges Nationwide
OraVerse (Phentolamine Mesylate) injection is being recalled nationwide due to defective cracked or broken cartridges. Novocol Pharmaceutical is recalling 1,636 cartons of the affected product.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves defective containers with no reported illnesses or injuries. The cracked cartridges pose a theoretical risk to medication integrity, qualifying this as a risk-of-harm product where injury has not yet been reported, warranting a Score 3.
Plain-English summary
OraVerse is a phentolamine mesylate injection used in dental procedures to reverse the effects of local anesthetics. Novocol Pharmaceutical of Canada, Inc. is recalling Lot D05004E of OraVerse (Phentolamine Mesylate) Injection due to defective cartridges that may be cracked or broken. The FDA has classified this as a Class II recall.
The affected product includes 1,636 cartons of OraVerse Injection, 0.4 mg/1.7mL, which were distributed nationwide in the United States. These cartridges have an expiration date of April 30, 2027. The defective containers pose a risk to product integrity and proper medication delivery.
Parties who have received the affected lot should verify whether their product is from the recalled batch using the lot number D05004E. Healthcare providers and organizations should follow standard recall procedures for handling and reporting.
The recalled product
- Product
- ORAVERSE (PHENTOLAMINE MESYLATE)
- Brand
- ORAVERSE
- Manufacturer
- Novocol Pharmaceutical of Canada, Inc.
- Category
- Drug
- Hazard
- defective-container
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: D05004E
- expires: 04-30-2027
Distribution
Distributed nationwide across the United States.
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