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23,608 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,311 8k filing · 2,000 device pma · 2,000 device recall
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23,608 catalysts · 5,000 device 510k · 4,728 grant · 3,778 approval · 3,311 8k filing · 2,000 device pma · 2,000 device recall
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03 — Reason: Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study. — Status: Terminated
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25 — Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. — Status: Terminated
FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles — Reason: Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone. — Status: Ongoing
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25 — Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment. — Status: Terminated
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01 — Reason: Failed Impurities/Degradation Specifications — Status: Terminated
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack — Reason: Crystallization — Status: Ongoing
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15 — Reason: LABELING: LABEL MIX-UP — Status: Ongoing
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Product code: PCH. Advisory committee: Microbiology. Type: Special
Product code: JFB. Advisory committee: Physical Medicine. Type: Special
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: MSX. Advisory committee: Cardiovascular. Type: Traditional
Product code: LBH. Advisory committee: Dental. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Traditional
Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Abbreviated
Product code: LZA. Advisory committee: General Hospital. Type: Special
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QKQ. Advisory committee: Pathology. Type: Traditional
Product code: OAS. Advisory committee: Radiology. Type: Traditional
Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL
Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL
Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS
Product code: JAD. Advisory committee: Radiology. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: HXA. Advisory committee: Orthopedic. Type: Traditional
Product code: DTE. Advisory committee: Cardiovascular. Type: Traditional
Product code: QWO. Advisory committee: Radiology. Type: Traditional
Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional
Product code: KNT. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Dual Track
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: EMA. Advisory committee: Dental. Type: Traditional
Product code: OLI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Special
Product code: PCH. Advisory committee: Microbiology. Type: Traditional
Product code: JMT. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Special
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PRE. Advisory committee: Microbiology. Type: Traditional
Product code: HGM. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: JAQ. Advisory committee: Radiology. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: LCJ. Advisory committee: Unknown. Type: Special
Sponsor: TORRENT. Form: TABLET. Route: ORAL
Product code: IRP. Advisory committee: Physical Medicine. Type: Special