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120 catalysts · 33 grant · 29 approval · 25 device recall · 16 recall · 10 device 510k · 7 device pma
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120 catalysts · 33 grant · 29 approval · 25 device recall · 16 recall · 10 device 510k · 7 device pma
Sponsor: SOBI. Form: CAPSULE. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL
Sponsor: PADAGIS US. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: GRANULES. Form: TABLET. Route: ORAL
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: PADAGIS ISRAEL. Form: OIL. Route: TOPICAL
Sponsor: PADAGIS ISRAEL. Form: OIL/DROPS. Route: OTIC
Sponsor: MICRO LABS. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: MICRO LABS. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: TEVA BRANDED PHARM. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: ANNORA PHARMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ACCORD HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: ACCORD HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: ACS DOBFAR SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: ACS DOBFAR SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: SANDOZ. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: LUPIN. Form: CAPSULE. Route: ORAL
Sponsor: CREEKWOOD PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: CREEKWOOD PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: CREEKWOOD PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: AIPING PHARM INC. Form: CAPSULE. Route: ORAL
Sponsor: JUBILANT GENERICS. Form: TABLET. Route: ORAL
Sponsor: SEBELA WOMENS HLTH. Form: SYSTEM. Route: INTRAUTERINE
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
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NZT. Advisory committee: Radiology. Type: Traditional
Product code: LYK. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Special
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional