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19,130 catalysts · 4,728 grant · 3,183 8k filing · 2,679 approval · 2,475 device 510k · 2,000 device recall · 1,737 device pma
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19,130 catalysts · 4,728 grant · 3,183 8k filing · 2,679 approval · 2,475 device 510k · 2,000 device recall · 1,737 device pma
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01. — Reason: Presence of foreign tablets/capsules. — Status: Ongoing
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2 — Reason: Lack of Assurance of Sterility — Status: Ongoing
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01 — Reason: Marketed Without an Approved NDA/ANDA — Status: Ongoing
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62 — Reason: Discoloration; discolored solution from cracked vials — Status: Ongoing
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 — Reason: Lack of Assurance of Sterility — Status: Ongoing
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10. — Reason: Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks. — Status: Ongoing
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PMP. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: Real-Time Process. Product code: MAQ. Advisory committee: MI. Decision: APPR
Product code: PQP. Advisory committee: PA. Decision: APPR
Supplement type: Real-Time Process. Product code: PNJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
GE HealthCare OEC 9900 Elite C-arm Systems. — Reason: GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user. — Status: Ongoing
GE HealthCare OEC 9800. — Reason: GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user. — Status: Ongoing
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28 — Reason: Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output. — Status: Ongoing
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ONG. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MBF. Advisory committee: Orthopedic. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: IWB. Advisory committee: Radiology. Type: Traditional
Product code: OXO. Advisory committee: Radiology. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Special