Lee Pharmaceuticals, Inc
FDA Regulatory Profile
Lee Pharmaceuticals, Inc appears in FDA public data with 1 recall, 29 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-161-2013, Class II) was initiated on December 21, 2012. Its most recent 510(k) clearance was granted on March 31, 1993.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 29
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-161-2013 | Class II | 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HO | December 21, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K924378 | RESTOBOND 4 | March 31, 1993 |
| K912256 | PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT | July 24, 1991 |
| K900809 | LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS | June 28, 1990 |
| K894315 | RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT | October 31, 1989 |
| K881903 | PROSTHODENT VL | July 1, 1988 |
| K873123 | LEE COMPOSITE INLAY SYSTEM | January 20, 1988 |
| K863157 | RESTODENT POSTERIOR | September 25, 1986 |
| K854882 | PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT | January 30, 1986 |
| K844133 | CLEANSE N BOND I | January 4, 1985 |
| K844134 | CLEANSE N BOND II | January 4, 1985 |
| K843363 | RESTODENT VL | October 25, 1984 |
| K840726 | RESTODENT DENTIN BONDING AGENT | June 27, 1984 |
| K810923 | LEE ENDOFILL, ROOT CANAL FILLING RESIN | April 21, 1981 |
| K810517 | INSTA-BOND | March 24, 1981 |
| K781977 | APPLICATOR, LEE IMPRESSION | December 20, 1978 |
| K781243 | MERCURY DISP. CAPSULE | September 20, 1978 |
| K780966 | LEE-ALLOY DISPOSABLE CAPSULES | August 21, 1978 |
| K781242 | ALLOY, AMALGAM, DISP. CAPSULE | August 21, 1978 |
| K780965 | NEW RESTODENT | June 22, 1978 |
| K780967 | LEE-ALLOY | June 22, 1978 |