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23,484 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,187 8k filing · 2,000 device pma · 2,000 device recall
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23,484 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,187 8k filing · 2,000 device pma · 2,000 device recall
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles). — Reason: Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing. — Status: Ongoing
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01. — Reason: Failed Impurities/Degradation Specification — Status: Ongoing
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC: 36000-364-01 — Reason: Labeling: Missing Label — Status: Ongoing
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155 — Reason: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. — Status: Ongoing
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317 — Reason: Presence of Particulate Matter: Presence of glass particulates. — Status: Terminated
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018 — Reason: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. — Status: Ongoing
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01. — Reason: Failed Impurities/Degradation Specification — Status: Ongoing
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: EFB. Advisory committee: Dental. Type: Traditional
Product code: SDG. Advisory committee: Neurology. Type: Direct
Product code: FRO. Advisory committee: Unknown. Type: Special
Product code: OPP. Advisory committee: General Hospital. Type: Special
Product code: OLK. Advisory committee: Cardiovascular. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Sponsor: EISAI INC. Form: INJECTABLE. Route: INJECTION
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: ONF. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MSX. Advisory committee: Cardiovascular. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: CAH. Advisory committee: Anesthesiology. Type: Traditional
Product code: POK. Advisory committee: Radiology. Type: Traditional
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION
Sponsor: SYNDAX. Form: TABLET. Route: ORAL
Product code: OTM. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Traditional
Product code: ELW. Advisory committee: Dental. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: QFM. Advisory committee: Radiology. Type: Traditional
Product code: POK. Advisory committee: Radiology. Type: Traditional
Product code: DSY. Advisory committee: Cardiovascular. Type: Traditional
Product code: QRL. Advisory committee: General, Plastic Surgery. Type: Special
Product code: LLZ. Advisory committee: Radiology. Type: Abbreviated
Product code: LIT. Advisory committee: Cardiovascular. Type: Traditional
Product code: SDJ. Advisory committee: Cardiovascular. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Traditional
Advisory committee: Unknown. Type: Traditional
Product code: MQE. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Special
Product code: NLH. Advisory committee: Cardiovascular. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional