calendar
21,862 catalysts · 4,728 grant · 4,071 device 510k · 3,311 8k filing · 3,114 approval · 2,000 device pma · 2,000 device recall
next 91 dayslessmore
MonWedFri
21,862 catalysts · 4,728 grant · 4,071 device 510k · 3,311 8k filing · 3,114 approval · 2,000 device pma · 2,000 device recall
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05. — Reason: Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim. — Status: Ongoing
Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11. — Reason: cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product. — Status: Terminated
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10. — Reason: CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit. — Status: Ongoing
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01 — Reason: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. — Status: Ongoing
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: SEF. Advisory committee: General Hospital. Type: Traditional
Product code: BZQ. Advisory committee: Anesthesiology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: GWG. Advisory committee: Neurology. Type: Special
Product code: OMB. Advisory committee: Neurology. Type: Traditional
Product code: QQU. Advisory committee: Ophthalmic. Type: Traditional
Product code: FTL. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QBJ. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: OMB. Advisory committee: Neurology. Type: Traditional
Product code: SEC. Advisory committee: Physical Medicine. Type: Direct
Sponsor: ARGENX BV. Form: INJECTABLE. Route: INJECTION
Sponsor: ADIENNE SA. Form: POWDER. Route: INTRAVENOUS
Sponsor: RUBICON RESEARCH. Form: SOLUTION. Route: ORAL
Product code: OLZ. Advisory committee: Neurology. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Special
Product code: OVE. Advisory committee: Orthopedic. Type: Traditional
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: GXH. Advisory committee: Neurology. Type: Traditional
Product code: EBZ. Advisory committee: Dental. Type: Traditional
Product code: KNT. Advisory committee: Gastroenterology, Urology. Type: Traditional
Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION
Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS
Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: VIIV HLTHCARE. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR
Product code: EBZ. Advisory committee: Dental. Type: Traditional
Product code: MSY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: HIF. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FET. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NDN. Advisory committee: Orthopedic. Type: Traditional
Product code: QPF. Advisory committee: Neurology. Type: Traditional
Product code: EBW. Advisory committee: Dental. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: NQQ. Advisory committee: Radiology. Type: Traditional