calendar
20 catalysts · 10 device 510k · 5 device pma · 5 recall
next 91 dayslessmore
MonWedFri
20 catalysts · 10 device 510k · 5 device pma · 5 recall
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister) — Reason: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. — Status: Ongoing
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card). — Reason: cGMP deviations — Status: Ongoing
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5 — Reason: Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol — Status: Ongoing
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30 — Reason: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. — Status: Ongoing
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4 — Reason: Defective Container: This recall is being initiated due to a leaking unit stored horizontally. — Status: Ongoing
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: MVC. Advisory committee: PA. Decision: APPR
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: PZK. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: LXA. Advisory committee: CV. Decision: OK30
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HTY. Advisory committee: Orthopedic. Type: Traditional
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: BTR. Advisory committee: Anesthesiology. Type: Special
Product code: SAH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HQC. Advisory committee: Ophthalmic. Type: Traditional
Product code: KIF. Advisory committee: Dental. Type: Traditional