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21,153 catalysts · 4,728 grant · 3,704 device 510k · 3,126 8k filing · 3,015 approval · 2,000 device pma · 2,000 device recall
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21,153 catalysts · 4,728 grant · 3,704 device 510k · 3,126 8k filing · 3,015 approval · 2,000 device pma · 2,000 device recall
Product code: FRG. Advisory committee: General Hospital. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: NPR. Advisory committee: Hematology. Type: Special
Product code: DZJ. Advisory committee: Dental. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Abbreviated
Product code: FRG. Advisory committee: General Hospital. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: POK. Advisory committee: Radiology. Type: Traditional
Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION
Sponsor: MSN. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: SEBELA WOMENS HLTH. Form: SYSTEM. Route: INTRAUTERINE
Product code: FRG. Advisory committee: General Hospital. Type: Traditional
Product code: LZC. Advisory committee: General Hospital. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Traditional
Product code: QJI. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Product code: OHV. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: BAYER HLTHCARE. Form: TABLET. Route: ORAL
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: SDY. Advisory committee: Cardiovascular. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: GDW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: EIH. Advisory committee: Dental. Type: Special
Sponsor: SAPTALIS PHARMS. Form: CONCENTRATE. Route: ORAL
Sponsor: SHORLA. Form: SOLUTION. Route: INTRAVENOUS
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61 — Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. — Status: Ongoing
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01 — Reason: Lack of Assurance of Sterility — Status: Completed
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47. — Reason: Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch. — Status: Ongoing
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90 — Reason: Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%) — Status: Ongoing
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426 — Reason: Presence of Particulate Matter. — Status: Ongoing
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61. — Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. — Status: Ongoing
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing