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1,132 catalysts · 18,987 approval · 5,000 device 510k · 4,728 grant · 4,207 phase readout · 2,217 8k filing · 2,000 device pma
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1,132 catalysts · 18,987 approval · 5,000 device 510k · 4,728 grant · 4,207 phase readout · 2,217 8k filing · 2,000 device pma
PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6 — Reason: cGMP Deviations — Status: Terminated
THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 01056 6), Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 — Reason: cGMP Deviations — Status: Terminated
LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105 — Reason: cGMP Deviations — Status: Terminated
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01 — Reason: CGMP violations. — Status: Ongoing
EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%, Distributed by: Walmart Inc., Bentonville, AR 72716 NDC 79903-106-06 — Reason: cGMP Deviations — Status: Terminated
JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5 — Reason: cGMP Deviations — Status: Terminated
Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05 — Reason: cGMP Deviations — Status: Terminated
ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7 — Reason: cGMP Deviations — Status: Terminated
CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9 — Reason: cGMP Deviations — Status: Terminated
ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 — Reason: cGMP Deviations — Status: Terminated
HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC 8 45717 01072 6 — Reason: cGMP Deviations — Status: Terminated
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02 — Reason: CGMP violations. — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08 — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit — Status: Ongoing
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
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139 — Reason: cGMP Deviations: Out of specification results for micro in hand soap products. — Status: Ongoing
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. — Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit — Status: Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, 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 16714-554-01. — Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. — Status: Ongoing
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. — Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit — Status: Ongoing
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28 — Reason: Labeling: Label Mix-Up — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories — Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit — Status: Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01. — Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. — 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, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons). — Reason: Presence of Particulate Matter: Potential for glass delamination from the vials. — Status: Ongoing
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17 — Reason: Subpotent drug — Status: Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, 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 16714-555-01. — Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. — Status: Ongoing
Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons). — Reason: Presence of Particulate Matter: Potential for glass delamination from the vials. — Status: Ongoing
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30 — Reason: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. — Status: Ongoing
Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509 — Reason: cGMP Deviations: Out of specification results for micro in hand soap products. — Status: Ongoing
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