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Novocol Pharmaceutical of Canada, Inc. FDA Recalls

7 recalls on file across drugs, 0 of them Class I and 7 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton contaClass IIOct 31, 2025Defective container: cracked/broken cartridges
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton contaClass IIOct 31, 2025Defective container: cracked/broken cartridges
Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 SinClass IIOct 31, 2025Defective container: cracked/broken cartridges
Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containinClass IIOct 31, 2025Defective container: cracked/broken cartridges
Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged inClass IIOct 31, 2025Defective container: cracked/broken cartridges
darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged inClass IIOct 31, 2025Defective container: cracked/broken cartridges
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Class IIOct 31, 2025Defective container: cracked/broken cartridges

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