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20,660 catalysts · 4,728 grant · 3,374 device 510k · 3,189 8k filing · 2,856 approval · 2,000 device pma · 2,000 device recall
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20,660 catalysts · 4,728 grant · 3,374 device 510k · 3,189 8k filing · 2,856 approval · 2,000 device pma · 2,000 device recall
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01 — Reason: CGMP Deviations — Status: Terminated
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02 — Reason: CGMP Deviations — Status: Terminated
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07 — Reason: CGMP Deviations — Status: Terminated
Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01. — Reason: cGMP deviations — Status: Ongoing
CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052. — Reason: CGMP Deviations — Status: Terminated
KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0. — Reason: CGMP Deviations — Status: Terminated
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8 10096 77162 9. — Reason: CGMP Deviations — Status: Terminated
KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3. — Reason: CGMP Deviations — Status: Terminated
Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01 — Reason: CGMP Deviations — Status: Terminated
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31. — Reason: Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator. — Status: Ongoing
CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4. — Reason: CGMP Deviations — Status: Terminated
Supplement type: 30-Day Notice. Product code: JCW. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: KGG. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: FHW. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: EZY. Advisory committee: GU. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NIO. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: OAD. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30
Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: EGS. Advisory committee: Dental. Type: Abbreviated
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Special
Product code: QKB. Advisory committee: Radiology. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FRN. Advisory committee: General Hospital. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Sponsor: STERISCIENCE. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: ACCORD HLTHCARE. Form: SOLUTION. Route: INTRAVENOUS
Supplement type: 30-Day Notice. Product code: QWK. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: MJO. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: PRC. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: ONU. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NQR. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: NWX. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NHL. Advisory committee: NE. Decision: APPR
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: DRE. Advisory committee: Cardiovascular. Type: Special
Product code: SEU. Advisory committee: Cardiovascular. Type: Direct
Product code: ONO. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional