Novocol Recalls Subpotent Lidocaine and Epinephrine Dental Injection Lots
Novocol is recalling two lots of Lidocaine 2% with Epinephrine 1:100,000 injection because the epinephrine component may be subpotent.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating under the rubric.
Plain-English summary
Novocol Pharmaceutical of Canada is recalling two lots of Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection. The product is distributed under the names Octocaine 100 and 2% Xylocaine Dental. The recall is being conducted because the epinephrine component in these specific lots may be subpotent.
The affected lots are D00290 D (expiration 08/2013) and D00205 A (expiration 11/2013). A total of 12,497 boxes were distributed nationwide and in Canada. The product is a prescription-only medication intended for dental block and infiltration use.
Dental professionals and patients should stop using the affected lots and contact their supplier or the manufacturer for further instructions. The FDA has classified this recall as Class II, indicating a situation where use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
- Brand
- LIDOCAINE
- Manufacturer
- Novocol Pharmaceutical of Canada
- Category
- Drug — Dental Anesthetic
- Hazard
- Affected units
- 12,497
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 (4)
- Lot #s: D00290 D
- Exp 08/2013
- D00205 A
- Exp 11/2013
Distribution
Distributed nationwide across the United States.
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