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13,543 catalysts · 3,404 8k filing · 2,401 grant · 2,136 approval · 1,479 device 510k · 1,105 device recall · 1,000 device adverse event
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13,543 catalysts · 3,404 8k filing · 2,401 grant · 2,136 approval · 1,479 device 510k · 1,105 device recall · 1,000 device adverse event
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications. — Reason: Complaints of the ceramic tip of the resection sheath breaking have been received. — Status: Ongoing
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: PFIZER. Form: GEL. Route: TOPICAL
Sponsor: RUBICON RESEARCH. Form: SOLUTION. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: TABLET. Route: ORAL
Sponsor: INVAGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: INVAGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ALEMBIC. Form: CAPSULE, DELAYED RELEASE. Route: ORAL
Sponsor: ZYDUS. Form: CAPSULE, DELAYED RELEASE. Route: ORAL
Sponsor: PFIZER. Form: SWAB. Route: TOPICAL
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: SUSPENSION. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL
Sponsor: SEAGEN. Form: INJECTABLE. Route: INJECTION
Sponsor: PFIZER. Form: LOTION. Route: TOPICAL
Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7. — Reason: Subpotent drug; Clavulanate Potassium component — Status: Ongoing
Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01 — Reason: Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg. — Status: Ongoing
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India — Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. — Status: Ongoing
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India — Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. — Status: Ongoing
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. — Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. — Status: Ongoing
Product code: NKG. Advisory committee: Orthopedic. Type: Traditional
Product code: PGZ. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: OWN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NEW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: GXN. Advisory committee: Neurology. Type: Traditional
Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Traditional
Supplement type: 135 Review Track For 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: APPR
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration. — Reason: When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device. — Status: Ongoing
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Non-sterile; CT5504T ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Non-sterile; CT5505T ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Non-sterile; DP5001GT ChemoPlus Full Coverage Gown, Open Back, Large, medium Blue, Non- sterile; DP5002GT ChemoPlus Full Coverage Gown, Open Back, Extra Large, medium Blue, Non-sterile; DP5003GT ChemoPlus Full Coverage Gown, Open Back, Medium, medium Blue, Non-sterile; DP5004GT ChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, medium Blue, Non-sterile; CT5500TS ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Sterile; CT5502TS ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503TS ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Sterile; CT5504TS ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Sterile; CT5505TS ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Sterile; — Reason: Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years. — Status: Ongoing
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450 — Reason: Products may contain contamination, which may result in a darker or brown media color. — Status: Ongoing
Sponsor: RISING. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Sponsor: TEVA PHARMS INC. Form: TABLET. Route: ORAL
Sponsor: ASPIRO. Form: INJECTABLE. Route: INJECTION
Sponsor: KURA. Form: CAPSULE. Route: ORAL
Sponsor: IPCA LABS LTD. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INJECTION
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: SHANGHAI HENLIUS BIOTECH. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ZYDUS PHARMS. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: BARR. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: KAMAT. Form: SOLUTION. Route: ORAL
Sponsor: AMNEAL. Form: SOLUTION. Route: INJECTION, ORAL, RECTAL