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Novocol Pharmaceutical of Canada, Inc.: darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing

DrugsSource: FDA (drug) · Date: 2025-12-24

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Novocol Pharmaceutical of Canada, Inc.
Product
darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5.
Reason / hazard
Defective container: cracked/broken cartridges
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S.A. Nationwide
Recall initiated
2025-10-31
Code info
Lot: D05159G, expires: 07-31-2027
Product quantity
5,520 Cartons
Voluntary mandated
Voluntary: Firm initiated
City
Cambridge
Country
Canada
Event id
98080
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