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20,245 catalysts · 4,728 grant · 3,149 device 510k · 3,126 8k filing · 2,804 approval · 2,000 device pma · 2,000 device recall
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20,245 catalysts · 4,728 grant · 3,149 device 510k · 3,126 8k filing · 2,804 approval · 2,000 device pma · 2,000 device recall
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Abbreviated
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: KOJ. Advisory committee: Dental. Type: Traditional
Product code: SEP. Advisory committee: Microbiology. Type: Direct
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: QWS. Advisory committee: General Hospital. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: JAQ. Advisory committee: Radiology. Type: Traditional
Product code: PTF. Advisory committee: Microbiology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: QNP. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: OBJ. Advisory committee: Cardiovascular. Type: Special
Product code: POV. Advisory committee: Hematology. Type: Traditional
Product code: SCA. Advisory committee: Microbiology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Sponsor: BRISTOL-MYERS. Form: CAPSULE. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Product code: OWQ. Advisory committee: Cardiovascular. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: LHN. Advisory committee: Radiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: QPB. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OBO. Advisory committee: Ophthalmic. Type: Traditional
Product code: QHE. Advisory committee: Orthopedic. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: NKG. Advisory committee: Orthopedic. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: OHV. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KCT. Advisory committee: General Hospital. Type: Traditional
Product code: PTI. Advisory committee: General Hospital. Type: Special
Sponsor: GENENTECH. Form: VIAL. Route: SINGLE-USE
Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL
temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01. — Reason: CGMP Deviations — Status: Ongoing
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02 — Reason: CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets. — Status: Ongoing
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15. — Reason: cGMP deviations and lack of assurance of sterility. — Status: Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01. — Reason: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. — Status: Ongoing
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box) — Reason: Presence of Particulate Matter — Status: Ongoing
TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01 — Reason: Presence of Particulate Matter: Glass particles were found in pellet vials. — Status: Ongoing
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15. — Reason: cGMP deviations and lack of assurance of sterility. — Status: Ongoing
TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01 — Reason: Presence of Particulate Matter: Glass particles were found in pellet vials. — Status: Ongoing
FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15. — Reason: cGMP deviations and lack of assurance of sterility. — Status: Ongoing
TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0122-01 — Reason: Presence of Particulate Matter: Glass particles were found in pellet vials. — Status: Ongoing