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Recall Observatory FDA recall evidence

Drug 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.

D-0233-2026

October 31, 2025

Class II

Product summary

Firm
Novocol Pharmaceutical of Canada, Inc.
Event
Event 98080
Status
Ongoing
Classification
Class II
Quantity
40 cartons
Official record key
drug-enforcement:D-0233-2026

Official wording

Reason: Defective container: cracked/broken cartridges

Code information: Lot: D05159I, expires: 07-31-2027

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective container: cracked/broken cartridges