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2,916 catalysts · 3,288 8k filing · 2,435 grant · 2,379 approval · 1,691 device 510k · 1,229 device recall · 1,158 device pma
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2,916 catalysts · 3,288 8k filing · 2,435 grant · 2,379 approval · 1,691 device 510k · 1,229 device recall · 1,158 device pma
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Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52 — Reason: CGMP Deviations: Market complaints received for gritty texture (grainy) — Status: Ongoing
edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ. — Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. — Status: Ongoing
TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14 — Reason: Cross Contamination with Other Products. — Status: Ongoing
Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14 — Reason: Cross Contamination with Other Products. — Status: Ongoing
ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210 — Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. — Status: Ongoing
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01 — Reason: Failed Impurities/Degradation Specifications: — Status: Ongoing
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01 — Reason: Failed Impurities/Degradation Specifications: — Status: Ongoing
mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210 — Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. — Status: Ongoing
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01 — Reason: Failed Impurities/Degradation Specifications: — Status: Ongoing
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01 — Reason: Failed Impurities/Degradation Specifications: — Status: Ongoing
Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave, Ste 200, Sacramento, CA 95825. — Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. — Status: Ongoing
READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25 — Reason: Subpotent drug — Status: Ongoing
Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211 — Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. — Status: Ongoing
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com — Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. — Status: Ongoing
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01 — Reason: Failed Impurities/Degradation Specifications: — Status: Ongoing
Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788. — Reason: cGMP Deviations — Status: Ongoing
VA grant. PI: Alan Benjamin McGuire
VA grant. PI: NEAL S. PEACHEY
VA grant. PI: Brittney C Muir
VA grant. PI: Aasef G Shaikh
VA grant. PI: JOHN A CURCI
VA grant. PI: MARK H. TUSZYNSKI
DA grant. $150,505. PI: Richard Macatee
VA grant. PI: Shirley Ann Cohen-Mekelburg
VA grant. PI: Haijing Wu Hallenbeck
VA grant. PI: Natalie Riblet
VA grant. PI: Juliana V. Baldo
VA grant. PI: Timothy Patrick Hogan
VA grant. PI: Nicole Michelle Weston
VA grant. PI: Takashi Hato
OD grant. $408,750. PI: Emily Kelley Presseller
VA grant. PI: Emily Treichler
TW grant. $164,984. PI: Theresa Stichick Betancourt
VA grant. PI: Kevin Edward Houston
VA grant. PI: Marianna Gasperi
VA grant. PI: ABIDEMI BOLU AJIBOYE
VA grant. PI: David Benner Lombard
VA grant. PI: Christina Lebonville
VA grant. PI: Harikrishna Nakshatri
VA grant. PI: Nathan Adam Boucher
VA grant. PI: Adam Patrick McGuire
VA grant. PI: Monica A Perez
VA grant. PI: Charlie M Wray
VA grant. PI: Hannah Grigorian
VA grant. PI: Sarah Shue
VA grant. PI: Marianne E Casilio
VA grant. PI: Jonathan E Elliott
VA grant. PI: Ziyad Al-Aly
EY grant. $199,749. PI: Christopher Dale Conrady
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. — Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity — Status: Ongoing