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19,257 catalysts · 4,728 grant · 3,310 8k filing · 2,679 approval · 2,475 device 510k · 2,000 device recall · 1,737 device pma
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19,257 catalysts · 4,728 grant · 3,310 8k filing · 2,679 approval · 2,475 device 510k · 2,000 device recall · 1,737 device pma
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18 — Reason: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15 — Reason: Subpotent Drug: Assay below the approved specification — Status: Ongoing
Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01 — Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label. — Status: Ongoing
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10 — Reason: Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. — Status: Ongoing
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313 — Reason: CGMP Deviations — Status: Ongoing
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88 — Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH). — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-15 — Reason: Subpotent Drug: Assay below the approved specification — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17 — Reason: Subpotent Drug: Assay below the approved specification — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17 — Reason: Subpotent Drug: Assay below the approved specification — Status: Ongoing
Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194 — Reason: CGMP Deviations — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17 — Reason: Subpotent Drug: Assay below the approved specification — Status: Ongoing
Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224 — Reason: CGMP Deviations — Status: Ongoing
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18 — Reason: CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17 — Reason: Subpotent Drug: Assay below the approved specification — Status: Ongoing
Supplement type: 30-Day Notice. Product code: MGB. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: LPM. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: PMP. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MRM. Advisory committee: CV. Decision: APPR
Supplement type: Special (Immediate Track). Product code: LZD. Advisory committee: DE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPW. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: DXY. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LSZ. Advisory committee: AN. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: NVN. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NKM. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NIK. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: NRZ. Advisory committee: OB. Decision: APPR
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed) — Reason: Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis). — Status: Ongoing
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MQF. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: NEU. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: ESW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DRF. Advisory committee: Cardiovascular. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: MANKIND PHARMA. Form: INJECTABLE. Route: INJECTION
Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: PA. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: APPR