Novocol Pharmaceutical Of Canada, Inc. FDA Record
- Latest inspection VAI · May 3, 2024
- No warning letters matched by name
Novocol Pharmaceutical Of Canada, Inc. has 9 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Novocol Pharmaceutical Of Canada, Inc." is on file.
- Latest recall
- D-0228-2026 · Class II · Oct 31, 2025
- Latest inspection
- May 3, 2024 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 9 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 10 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Novocol Pharmaceutical Of Canada, Inc.: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 7 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 1 | 0 |
| 2019 | 2 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 2 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0228-2026 | Class II | 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP)… | Oct 31, 2025 |
| D-0232-2026 | Class II | Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI… | Oct 31, 2025 |
| D-0233-2026 | Class II | Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a… | Oct 31, 2025 |
| D-0231-2026 | Class II | darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI… | Oct 31, 2025 |
| D-0234-2026 | Class II | OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10… | Oct 31, 2025 |
| D-0229-2026 | Class II | Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged… | Oct 31, 2025 |
| D-0230-2026 | Class II | 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP)… | Oct 31, 2025 |
| D-0127-2021 | Class III | Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of… | Nov 20, 2020 |
| D-923-2013 | Class II | Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and… | Aug 14, 2013 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 3, 2024 | Cambridge, Canada | Drugs | Voluntary Action Indicated (VAI) | 3002807757 |
| Jan 30, 2020 | Cambridge, Canada | Drugs | No Action Indicated (NAI) | 3002807757 |
| Jun 21, 2019 | Cambridge, Canada | Drugs | No Action Indicated (NAI) | 3002807757 |
| Jun 18, 2019 | Cambridge, Canada | Drugs | Voluntary Action Indicated (VAI) | 3002807757 |
| Jul 26, 2017 | Cambridge, Canada | Drugs | Voluntary Action Indicated (VAI) | 3002807757 |
| May 16, 2017 | Cambridge, Canada | Drugs | Voluntary Action Indicated (VAI) | 3002807757 |
| Aug 11, 2015 | Cambridge, Canada | Drugs | Voluntary Action Indicated (VAI) | 3002807757 |
| Nov 11, 2014 | Cambridge, Canada | Drugs | Voluntary Action Indicated (VAI) | 3002807757 |
| Apr 20, 2012 | Cambridge, Canada | Drugs | Voluntary Action Indicated (VAI) | 3002807757 |
| Oct 22, 2010 | Cambridge, Canada | Drugs | Voluntary Action Indicated (VAI) | 3002807757 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002807757 | Cambridge, Canada | 10 | May 3, 2024 |
Novocol Pharmaceutical Of Canada, Inc. and the FDA: common questions
Has Novocol Pharmaceutical Of Canada, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Novocol Pharmaceutical Of Canada, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Novocol Pharmaceutical Of Canada, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Novocol Pharmaceutical Of Canada, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Novocol Pharmaceutical Of Canada, Inc.?
The most recent FDA inspection on file ended May 3, 2024 at Cambridge, Canada and was classified VAI. FDA has 10 inspections of Novocol Pharmaceutical Of Canada, Inc. on file.
Has Novocol Pharmaceutical Of Canada, Inc. had an FDA recall?
Yes. Novocol Pharmaceutical Of Canada, Inc. has 9 FDA recalls on record. The most recent started Oct 31, 2025.
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