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23,746 catalysts · 5,000 device 510k · 4,728 grant · 3,915 approval · 3,312 8k filing · 2,000 device pma · 2,000 device recall
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23,746 catalysts · 5,000 device 510k · 4,728 grant · 3,915 approval · 3,312 8k filing · 2,000 device pma · 2,000 device recall
ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com — Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. — Status: Ongoing
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37 — Reason: Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity. — Status: Terminated
10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in USA, Onlyyourrx.com. — Reason: CGMP Deviations: Inconsistency in the water systems. — Status: Ongoing
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com — Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. — Status: Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets — Reason: Labeling: Not Elsewhere Classified - Wrong NDC number — Status: Ongoing
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30 — Reason: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. — Status: Ongoing
boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015 — Reason: cGMP Deviations: Out of specification results for micro in hand soap products. — Status: Ongoing
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com — Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. — Status: Ongoing
ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com — Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac. — Status: Ongoing
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30 — Reason: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. — Status: Ongoing
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit — Status: Ongoing
Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670 — Reason: cGMP Deviations: Out of specification results for micro in hand soap products. — Status: Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01. — Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. — Status: Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01. — Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. — Status: Ongoing
Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339 — Reason: cGMP Deviations: Out of specification results for micro in hand soap products. — Status: Ongoing
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons). — Reason: Presence of Particulate Matter: Potential for glass delamination from the vials. — Status: Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01. — Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. — Status: Ongoing
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05 — Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit — Status: Ongoing
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit — Status: Ongoing
MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303 — Reason: cGMP Deviations: Out of specification results for micro in hand soap products. — Status: Ongoing
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit — Status: Ongoing
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28 — Reason: Labeling: Label Mix-Up — Status: Ongoing
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: JXM. Advisory committee: Clinical Toxicology. Type: Special
Product code: NDC. Advisory committee: Anesthesiology. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: KWQ. Advisory committee: Orthopedic. Type: Traditional
Product code: OWX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PKC. Advisory committee: Orthopedic. Type: Traditional
Product code: DZJ. Advisory committee: Dental. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: QFM. Advisory committee: Radiology. Type: Special
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GXZ. Advisory committee: Neurology. Type: Traditional
Sponsor: PFIZER. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Product code: EBD. Advisory committee: Dental. Type: Traditional
Product code: GWL. Advisory committee: Neurology. Type: Special
Product code: OPT. Advisory committee: Ophthalmic. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Special
Product code: FZE. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: FRC. Advisory committee: General Hospital. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Special
Product code: KIF. Advisory committee: Dental. Type: Traditional
Product code: GWF. Advisory committee: Neurology. Type: Special
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional