FDA-Drug2025-12-24Class IIPACKAGING DEFECT

Novocol lidocaine HCI and epinephrine injection recalled for cracked cartridges

GLASSNationwide distributionDrugs

What this means

Novocol Pharmaceutical's lidocaine HCI 2% and epinephrine injection cartridges (50-count boxes) may have cracks or breaks in the containers. This defect could affect the sterility and safety of the medication. The affected lot D05362A expires July 31, 2027.

  • Check if you have lot D05362A (NDC 50227-1030-5) with expiration date 07-31-2027
  • Do not use cartridges from this lot
  • Contact your dental or medical supplier or Patterson Dental Supply for instructions on return or replacement
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The agency's original wording
Hazard

Defective container: cracked/broken cartridges

Intended for
Adults
Illnesses reported
None reported
Sold states
U.S.A. Nationwide
Affected count
12,033 cartons
Manufactured in
25 Wolseley Crt, Cambridge, Canada
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0229-2026

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