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20,462 catalysts · 4,728 grant · 3,282 device 510k · 3,126 8k filing · 2,831 approval · 2,000 device pma · 2,000 device recall
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20,462 catalysts · 4,728 grant · 3,282 device 510k · 3,126 8k filing · 2,831 approval · 2,000 device pma · 2,000 device recall
Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02 — Reason: cGMP deviations — Status: Terminated
DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15 — Reason: cGMP deviations — Status: Terminated
HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01. — Reason: Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification.. — Status: Terminated
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11. — Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. — Status: Ongoing
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01 — Reason: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study. — Status: Terminated
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11 — Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. — Status: Ongoing
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11 — Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. — Status: Ongoing
Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363 — Reason: CGMP Deviations — Status: Ongoing
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11, — Reason: Lack of Assurance of Sterility: Leaking/damaged syringes. — Status: Ongoing
Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99 — Reason: cGMP deviations — Status: Terminated
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00 — Reason: CGMP Deviations — Status: Ongoing
Product code: DWJ. Advisory committee: Cardiovascular. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: JKA. Advisory committee: Clinical Chemistry. Type: Special
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: HKI. Advisory committee: Ophthalmic. Type: Traditional
Product code: OVD. Advisory committee: Orthopedic. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Special
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: JPA. Advisory committee: Hematology. Type: Special
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Sponsor: ABBVIE. Form: CAPSULE, DELAYED REL PELLETS. Route: ORAL
Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ABBVIE. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Special
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Special
Product code: HSN. Advisory committee: Orthopedic. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Special
Product code: KDN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: MEH. Advisory committee: Orthopedic. Type: Traditional
Product code: DXF. Advisory committee: Cardiovascular. Type: Special
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: DSA. Advisory committee: Cardiovascular. Type: Special
Product code: CHL. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional