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Recall Observatory FDA recall evidence

Drug product

Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.

D-0232-2026

October 31, 2025

Class II

Product summary

Firm
Novocol Pharmaceutical of Canada, Inc.
Event
Event 98080
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0232-2026

Official wording

Reason: Defective container: cracked/broken cartridges

Code information: Lot: D05159H, 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