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23,263 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,312 8k filing · 2,000 device pma · 2,000 device recall
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23,263 catalysts · 4,900 device 510k · 4,728 grant · 3,532 approval · 3,312 8k filing · 2,000 device pma · 2,000 device recall
Product code: LQR. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: JXG. Advisory committee: Neurology. Type: Traditional
Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Abbreviated
Product code: DPS. Advisory committee: Cardiovascular. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: HKI. Advisory committee: Ophthalmic. Type: Traditional
Product code: MID. Advisory committee: Immunology. Type: Traditional
Product code: JOJ. Advisory committee: General Hospital. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: PSY. Advisory committee: Pathology. Type: Special
Product code: EBI. Advisory committee: Dental. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HHW. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: QLQ. Advisory committee: Orthopedic. Type: Traditional
Sponsor: XCOVERY. Form: CAPSULE. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL
Sponsor: ELI LILLY AND CO. Form: CAPSULE. Route: ORAL
Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-443-20 — Reason: Subpotent and Superpotent Drug — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-040-20 — Reason: Subpotent and Superpotent Drug — Status: Ongoing
Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-442-20 — Reason: Subpotent and Superpotent Drug — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-445-20 — Reason: Subpotent and Superpotent Drug — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-039-20 — Reason: Subpotent and Superpotent Drug — Status: Ongoing
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81 — Reason: CGMP Deviations: Released product should have been rejected. — Status: Terminated
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing
Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-041-20 — Reason: Subpotent and Superpotent Drug — Status: Ongoing
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04. — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60 — Reason: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit — Status: Ongoing
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60 — Reason: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit — Status: Ongoing
Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing
Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing
Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing
Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. — Reason: Superpotent Drug and Subpotent Drug: potency failures obtained — Status: Ongoing