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21,470 catalysts · 4,728 grant · 3,890 device 510k · 3,189 8k filing · 3,063 approval · 2,000 device pma · 2,000 device recall
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21,470 catalysts · 4,728 grant · 3,890 device 510k · 3,189 8k filing · 3,063 approval · 2,000 device pma · 2,000 device recall
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: MLO. Advisory committee: Cardiovascular. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional
Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL
Sponsor: ITERUM THERAP. Form: TABLET. Route: ORAL
Product code: OBJ. Advisory committee: Cardiovascular. Type: Traditional
Product code: QMI. Advisory committee: Microbiology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MRW. Advisory committee: Unknown. Type: Traditional
Product code: LFL. Advisory committee: Unknown. Type: Traditional
Product code: EXQ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: SAI. Advisory committee: Orthopedic. Type: Traditional
Product code: QEZ. Advisory committee: Cardiovascular. Type: Special
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: OVD. Advisory committee: Orthopedic. Type: Special
Product code: BSP. Advisory committee: Anesthesiology. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: NEU. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: FRESENIUS KABI USA LLC. Form: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Product code: PPN. Advisory committee: Cardiovascular. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Special
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: INJECTION
Sponsor: ABBVIE. Form: SOLUTION. Route: ORAL
Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: EXELIXIS INC. Form: TABLET. Route: ORAL
CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc — Reason: Chemical contamination: presence of benzene — Status: Ongoing
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box). — Reason: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. — Status: Ongoing
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93 — Reason: Failed Dissolution Specifications - low dissolution results — Status: Ongoing
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05 — Reason: Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20. — Reason: Super-Potent Drug: Out of specification potency results were obtained. — Status: Ongoing
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04 — Reason: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. — Status: Ongoing
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30. — Reason: Subpotent Drug — Status: Ongoing
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30. — Reason: Subpotent Drug — Status: Ongoing
Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015 — Reason: Chemical contamination: presence of benzene — Status: Ongoing
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency. — Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil. — Status: Ongoing
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box). — Reason: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20. — Reason: Super-Potent Drug: Out of specification potency results were obtained. — Status: Ongoing
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04 — Reason: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. — Status: Ongoing
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30 — Reason: Failed Dissolution Specifications — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. — Status: Ongoing
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: DSP. Advisory committee: Cardiovascular. Type: Special
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional