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5,854 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 2,984 8k filing · 2,000 device pma
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5,854 catalysts · 18,987 approval · 5,811 phase readout · 5,000 device 510k · 4,728 grant · 2,984 8k filing · 2,000 device pma
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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
Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL). — Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns — Status: Ongoing
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. — Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity — Status: Ongoing
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1. — Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns — Status: Ongoing
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11) — Reason: Failed Dissolution Specifications. — Status: Ongoing
AA grant. $39,309. PI: Hanna Marie Hebden
Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing
GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing
L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing
N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing