Dental anesthetic injection recalled due to defective cartridges
Polocaine (mepivacaine hydrochloride) 3% dental injection is recalled due to cracked or broken cartridge containers that may compromise sterility. Affected lot D05159C distributed nationwide.
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: FDA Class II recall for a pharmaceutical injection product with defective containers. No reported illnesses or injuries have been associated with this defect. Meets the rubric criterion for High severity: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Novocol Pharmaceutical of Canada, Inc., on behalf of Dentsply Pharmaceutical, is recalling Polocaine (mepivacaine hydrochloride 3%) dental injection solution due to defective cartridge containers. The cartridges in affected lots contain cracks or breaks that compromise the integrity of the container.
The recall affects 5,825 cartridges distributed nationwide in the United States. The affected lot is D05159C with an expiration date of July 31, 2027. Each carton contains 50 single-dose cartridges of 1.7 mL each, intended for use as a local anesthetic in dental procedures.
Cracked or broken cartridges may introduce contamination and compromise the sterility of the injectable solution. Healthcare facilities that have received cartridges from the affected lot should stop using them immediately. Unused cartridges should not be used and should be returned to the distributor or disposed of according to applicable regulations.
The recalled product
- Product
- POLOCAINE (MEPIVACAINE HYDROCHLORIDE)
- Brand
- POLOCAINE
- Manufacturer
- Novocol Pharmaceutical of Canada, Inc.
- Category
- Drug
- Hazard
- container-defect
- contamination-risk
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: D05159C
- expires: 07-31-2027
Distribution
Distributed nationwide across the United States.
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