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20,692 catalysts · 4,728 grant · 3,346 device 510k · 3,267 8k filing · 2,850 approval · 2,000 device pma · 2,000 device recall
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20,692 catalysts · 4,728 grant · 3,346 device 510k · 3,267 8k filing · 2,850 approval · 2,000 device pma · 2,000 device recall
Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. — Reason: Cross Contamination — Status: Ongoing
Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-638-01 — Reason: CGMP Deviations — Status: Ongoing
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons) — Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination — Status: Ongoing
Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-678-60 — Reason: CGMP Deviations — Status: Ongoing
Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401, Made in the USA, UPC 7 35786 01921 1, UPC 8 42944 10223 1, and also packaged as a twin pack UPC 8 42944 10241 5, — Reason: Chemical contamination: Presence of benzene — Status: Ongoing
Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-408-60 — Reason: CGMP Deviations — Status: Ongoing
Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-573-30 — Reason: CGMP Deviations — Status: Ongoing
Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. — Reason: CGMP Deviations — Status: Ongoing
Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-424-30 — Reason: CGMP Deviations — Status: Ongoing
Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-336-01 — Reason: CGMP Deviations — Status: Ongoing
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: IZF. Advisory committee: Radiology. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LEL. Advisory committee: Neurology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION
Product code: PLQ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: QER. Advisory committee: Ophthalmic. Type: Traditional
Product code: QDG. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Special
Product code: OBP. Advisory committee: Neurology. Type: Traditional
Product code: SEM. Advisory committee: Neurology. Type: Direct
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: OCW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: OAS. Advisory committee: Radiology. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: QCI. Advisory committee: Neurology. Type: Traditional
Sponsor: ASTRAZENECA AB. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Product code: DCK. Advisory committee: Immunology. Type: Traditional
Product code: PKL. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: MQB. Advisory committee: Radiology. Type: Special
Product code: PSZ. Advisory committee: Microbiology. Type: Dual Track
Product code: ONE. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Special
Product code: KPE. Advisory committee: General Hospital. Type: Traditional
Product code: PEN. Advisory committee: Microbiology. Type: Traditional
Product code: DXZ. Advisory committee: Cardiovascular. Type: Traditional