Recalls / Class II
Class IID-0233-2026
Product
Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05.
- Brand name
- Carbocaine
- Generic name
- Mepivacaine Hydrochloride
- Active ingredient
- Mepivacaine Hydrochloride
- Route
- Submucosal
- NDC
- 0362-0753
- FDA application
- ANDA088387
- Affected lot / code info
- Lot: D05159I, expires: 07-31-2027
Why it was recalled
Defective container: cracked/broken cartridges
Recalling firm
- Firm
- Novocol Pharmaceutical of Canada, Inc.
- Manufacturer
- Septodont, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 25 Wolseley Crt, Cambridge, N/A, Canada
Distribution
- Quantity
- 40 cartons
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2025-10-31
- FDA classified
- 2025-12-12
- Posted by FDA
- 2025-12-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0233-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.