Recalling firm
Novocol Pharmaceutical of Canada, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-12-24
Distribution
U.S.A. Nationwide
Product quantity
40 cartons
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective container: cracked/broken cartridges
Product description
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.
Code / lot info
Lot: D05159I, expires: 07-31-2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.