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Recall Observatory FDA recall evidence

Drug product

Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5.

D-0229-2026

October 31, 2025

Class II

Product summary

Firm
Novocol Pharmaceutical of Canada, Inc.
Event
Event 98080
Status
Ongoing
Classification
Class II
Quantity
12,033 cartons
Official record key
drug-enforcement:D-0229-2026

Official wording

Reason: Defective container: cracked/broken cartridges

Code information: Lot: D05362A, 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