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4,311 catalysts · 4,728 grant · 4,492 device 510k · 3,288 8k filing · 3,218 approval · 2,000 device pma · 2,000 device recall
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4,311 catalysts · 4,728 grant · 4,492 device 510k · 3,288 8k filing · 3,218 approval · 2,000 device pma · 2,000 device recall
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Sponsor: IBSA INST BIO. Form: SYSTEM. Route: TOPICAL
Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: AUROBINDO PHARMA USA. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: AVION PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: ORAL
Sponsor: STEVENS J. Form: CAPSULE. Route: ORAL
Sponsor: BARR LABS INC. Form: TABLET. Route: ORAL
Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL
Sponsor: ENDO OPERATIONS. Form: TABLET. Route: ORAL
Sponsor: ANI PHARMS. Form: TABLET. Route: ORAL
Sponsor: NOVITIUM PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM INDUSTRIES. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS NY. Form: TABLET. Route: ORAL
Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL
Sponsor: INGENUS PHARMS NJ. Form: TABLET. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: AOP HLTH US. Form: POWDER. Route: INTRAVENOUS
Sponsor: LGM PHARMA. Form: TABLET. Route: ORAL
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL
Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: GILEAD SCIENCES INC. Form: TABLET. Route: ORAL
Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: ORAL
Sponsor: KAMAT. Form: SOLUTION. Route: ORAL
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
Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) 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
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) 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
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01 — Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. — Status: Ongoing
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3 — Reason: Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive). — Status: Ongoing
Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC# 68645-610-90. — Reason: Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet. — Status: Completed
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01 — Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. — Status: Ongoing
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01 — Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. — Status: Ongoing
Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL
Sponsor: NOVEN PHARMS INC. Form: SYSTEM. Route: TRANSDERMAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: AVYXA HOLDINGS. Form: POWDER. Route: INTRAVENOUS
Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL
Sponsor: PF PRISM CV. Form: CAPSULE. Route: ORAL