Prescription Lidocaine Injection Recalled for Cracked Cartridge Defect
Novocol Pharmaceutical is recalling lidocaine injection cartridges due to cracked or broken containers that could compromise drug integrity. The nationwide recall affects 12,033 cartons.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical with a structural defect (cracked or broken cartridges). No illnesses or injuries have been reported. The defect poses a potential risk of drug contamination or improper administration, justifying a High severity score per the rubric criterion for risk-of-harm products without yet-reported injury.
Plain-English summary
Novocol Pharmaceutical of Canada, Inc. is recalling lidocaine hydrochloride 2% with epinephrine 1:100,000 injection due to defective cartridge containers. The affected product is packaged in 1.7 ml single-dose cartridges, 50 per carton, and is used as a local anesthetic in dental procedures.
The recall applies to one lot (D05362A) with an expiration date of July 31, 2027. The defect involves cracked or broken cartridges that could compromise the integrity of the medication. These containers were distributed nationwide across the United States.
Dental professionals and facilities that have received this product should immediately stop using the affected lot. Contact Patterson Dental Supply or the manufacturer for instructions on returning the product or obtaining a replacement. Patients who have received injections from these cartridges should consult their dentist or healthcare provider if they have any concerns.
The recalled product
- Product
- LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
- Brand
- LIDOCAINE
- Manufacturer
- Novocol Pharmaceutical of Canada, Inc.
- Hazard
- container-defect
- cartridge-damage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: D05362A
- expires: 07-31-2027
Distribution
Distributed nationwide across the United States.
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