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23,824 catalysts · 5,000 device 510k · 4,728 grant · 3,955 approval · 3,350 8k filing · 2,000 device pma · 2,000 device recall
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23,824 catalysts · 5,000 device 510k · 4,728 grant · 3,955 approval · 3,350 8k filing · 2,000 device pma · 2,000 device recall
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit — Status: Ongoing
Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670 — Reason: cGMP Deviations: Out of specification results for micro in hand soap products. — Status: Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01. — Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. — Status: Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01. — Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. — Status: Ongoing
Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339 — Reason: cGMP Deviations: Out of specification results for micro in hand soap products. — Status: Ongoing
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons). — Reason: Presence of Particulate Matter: Potential for glass delamination from the vials. — Status: Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01. — Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. — Status: Ongoing
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05 — Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit — Status: Ongoing
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit — Status: Ongoing
MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303 — Reason: cGMP Deviations: Out of specification results for micro in hand soap products. — Status: Ongoing
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit — Status: Ongoing
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28 — Reason: Labeling: Label Mix-Up — Status: Ongoing
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: JXM. Advisory committee: Clinical Toxicology. Type: Special
Product code: NDC. Advisory committee: Anesthesiology. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: OWX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PKC. Advisory committee: Orthopedic. Type: Traditional
Product code: DZJ. Advisory committee: Dental. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: QFM. Advisory committee: Radiology. Type: Special
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GXZ. Advisory committee: Neurology. Type: Traditional
Sponsor: PFIZER. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Product code: EBD. Advisory committee: Dental. Type: Traditional
Product code: GWL. Advisory committee: Neurology. Type: Special
Product code: OPT. Advisory committee: Ophthalmic. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Special
Product code: FZE. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: FRC. Advisory committee: General Hospital. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Special
Product code: KIF. Advisory committee: Dental. Type: Traditional
Product code: GWF. Advisory committee: Neurology. Type: Special
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Sponsor: VERTEX PHARMS INC. Form: GRANULE. Route: ORAL
Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: CHECKPOINT THERAPEUTICS INC. Form: INJECTABLE. Route: INJECTION
Product code: CHL. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: MNS. Advisory committee: Anesthesiology. Type: Traditional
Product code: MNT. Advisory committee: Anesthesiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Special
Product code: NFO. Advisory committee: Neurology. Type: Traditional