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23,500 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,203 8k filing · 2,000 device pma · 2,000 device recall
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23,500 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,203 8k filing · 2,000 device pma · 2,000 device recall
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: LBH. Advisory committee: Dental. Type: Traditional
Product code: OLZ. Advisory committee: Neurology. Type: Traditional
Product code: QBC. Advisory committee: Neurology. Type: Traditional
Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: GILEAD SCIENCES INC. Form: TABLET. Route: ORAL
Product code: DQD. Advisory committee: Cardiovascular. Type: Traditional
Product code: MEH. Advisory committee: Orthopedic. Type: Special
Product code: FRC. Advisory committee: General Hospital. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: QDQ. Advisory committee: Radiology. Type: Traditional
Product code: PQA. Advisory committee: Microbiology. Type: Special
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: GXY. Advisory committee: Neurology. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: BZH. Advisory committee: Anesthesiology. Type: Traditional
Product code: QEY. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: ORAL
Sponsor: KAMAT. Form: SOLUTION. Route: ORAL
Product code: OMB. Advisory committee: Neurology. Type: Traditional
Product code: KDN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: DXF. Advisory committee: Cardiovascular. Type: Special
Product code: OVD. Advisory committee: Orthopedic. Type: Traditional
Product code: JAQ. Advisory committee: Radiology. Type: Traditional
Product code: EBG. Advisory committee: Dental. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OWY. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: EBG. Advisory committee: Dental. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05 — Reason: Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing. — Status: Terminated
Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India — Reason: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor — Status: Terminated
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05 — Reason: Failed Tablet/Capsule Specifications — Status: Ongoing
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70 — Reason: Failed Impurity/Degradation Specifications — Status: Terminated
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72 — Reason: Failed Impurity/Degradation Specifications — Status: Terminated
Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01 — Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. — Status: Ongoing
Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01 — Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. — Status: Ongoing
BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1 — Reason: Lack of Sterility Assurance — Status: Terminated