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17,759 catalysts · 4,648 grant · 3,603 8k filing · 2,587 approval · 1,903 device 510k · 1,502 device recall · 1,317 device pma
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17,759 catalysts · 4,648 grant · 3,603 8k filing · 2,587 approval · 1,903 device 510k · 1,502 device recall · 1,317 device pma
Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION
Sponsor: NE RX PHARMA. Form: TABLET. Route: ORAL
bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. — Reason: Failed Impurity/Degradation Specifications — Status: Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11) — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11) — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60. — Reason: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. — Status: Ongoing
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60. — Reason: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. — Status: Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11) — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03 — Reason: Superpotent drug — Status: Ongoing
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1 — Reason: Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide. — Status: Ongoing
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. — Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19. — Reason: Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). — Status: Ongoing
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. — Reason: Failed Impurity/Degradation Specifications — Status: Ongoing
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10. — Reason: cGMP deviations: Temperature excursion during transportation. — Status: Ongoing
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203. — Reason: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing
Product code: FRC. Advisory committee: General Hospital. Type: Special
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: OOE. Advisory committee: Ophthalmic. Type: Special
Product code: MUH. Advisory committee: Dental. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QFG. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: FET. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MVL. Advisory committee: Unknown. Type: Traditional
Product code: IZQ. Advisory committee: Cardiovascular. Type: Special
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: FDF. Advisory committee: Gastroenterology, Urology. Type: Traditional
Supplement type: 30-Day Notice. Product code: OZD. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: Special (Immediate Track). Product code: MOM. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MKT. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: MCN. Advisory committee: OB. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMG. Advisory committee: SU. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: OSR. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MAQ. Advisory committee: MI. Decision: APPR
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A — Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. — Status: Ongoing
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A — Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. — Status: Ongoing
Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A — Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. — Status: Ongoing
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A — Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. — Status: Ongoing
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY — Reason: Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation. — Status: Ongoing
HL grant. $606,057. PI: Mercedes Aurelia Bravo
HL grant. $1,380,474. PI: Andrew John Admon
CA grant. $3,355,681. PI: Philip Chow
MH grant. $853,969. PI: Jazmin Brown-Iannuzzi
NS grant. $49,538. PI: Margaret Mary Cassidy
CA grant. $2,691,173. PI: Igor Landry Bado
HL grant. $184,464. PI: Kevin Owen Murray
AI grant. $122,103. PI: Najib M El-Sayed