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21,811 catalysts · 4,728 grant · 3,987 device 510k · 3,377 8k filing · 3,107 approval · 2,000 device pma · 2,000 device recall
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21,811 catalysts · 4,728 grant · 3,987 device 510k · 3,377 8k filing · 3,107 approval · 2,000 device pma · 2,000 device recall
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
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61. — 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, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01. — Reason: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. — Status: Ongoing
Product code: OGZ. Advisory committee: Cardiovascular. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Special
Product code: NRY. Advisory committee: Cardiovascular. Type: Special
Product code: ONF. Advisory committee: General, Plastic Surgery. Type: Special
Product code: QRK. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FMK. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LJS. Advisory committee: General Hospital. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Special
Product code: FYA. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION
Product code: OWW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FBK. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: DSY. Advisory committee: Cardiovascular. Type: Traditional
Product code: GJS. Advisory committee: Hematology. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: NGZ. Advisory committee: Microbiology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: LIT. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)
Sponsor: LONG GROVE PHARMS. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ALKERMES INC. Form: TABLET. Route: ORAL
Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION
Sponsor: BAXTER HLTHCARE CORP. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION
Product code: MOL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: SAH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional