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57 catalysts · 24 approval · 11 recall · 10 device 510k · 9 device pma · 2 device recall · 1 grant
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57 catalysts · 24 approval · 11 recall · 10 device 510k · 9 device pma · 2 device recall · 1 grant
Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: KENVUE BRANDS. Form: AEROSOL, FOAM. Route: TOPICAL
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL
Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: TOPICAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL
Sponsor: LAURUS. Form: TABLET. Route: ORAL
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: LAURUS. Form: CAPSULE. Route: ORAL
Sponsor: SOMERSET THERAPS LLC. Form: TABLET
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: ORBICULAR. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET, DELAYED RELEASE. Route: ORAL
Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: TOPICAL
Sponsor: SANDOZ. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION
Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION
Sponsor: RISING. Form: CAPSULE. Route: ORAL
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887 — Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. — Status: Ongoing
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. — Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. — Status: Ongoing
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06. — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing
ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863 — Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. — Status: Ongoing
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA — Reason: cGMP Deviations — Status: Ongoing
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493 — Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. — Status: Ongoing
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA — Reason: cGMP Deviations — Status: Ongoing
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15 — Reason: Out of specification for dissolution. — Status: Ongoing
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30 — Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. — Status: Ongoing
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01. — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing
Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1 — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: OXO. Advisory committee: Radiology. Type: Traditional
Product code: GXN. Advisory committee: Neurology. Type: Traditional
Product code: MOS. Advisory committee: Radiology. Type: Special
Product code: LZC. Advisory committee: General Hospital. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Special
Product code: QJI. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: BTT. Advisory committee: Anesthesiology. Type: Traditional
Product code: KRD. Advisory committee: Cardiovascular. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: Special (Immediate Track). Product code: LMH. Advisory committee: SU. Decision: APPR
Supplement type: Special (Immediate Track). Product code: MCX. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: SDL. Advisory committee: AN. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30