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17 catalysts · 9 device 510k · 5 recall · 3 approval
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17 catalysts · 9 device 510k · 5 recall · 3 approval
Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2 — Reason: Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use. — Status: Terminated
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA. — Reason: CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit — Status: Terminated
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73. — Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules — Status: Ongoing
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01 — Reason: cGMP Deviations: Product intended for quarantine was inadvertently distributed. — Status: Ongoing
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73. — Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules — Status: Ongoing
Product code: OLP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: IPF. Advisory committee: Physical Medicine. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: MAI. Advisory committee: Orthopedic. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: FMF. Advisory committee: General Hospital. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special