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18,629 catalysts · 4,728 grant · 3,685 8k filing · 2,621 approval · 2,129 device 510k · 1,725 device recall · 1,490 device pma
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18,629 catalysts · 4,728 grant · 3,685 8k filing · 2,621 approval · 2,129 device 510k · 1,725 device recall · 1,490 device pma
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50 — Reason: Presence of Particulate Matter — Status: Ongoing
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-047-88. — Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. — Status: Ongoing
Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01 — Reason: CGMP Deviations: Potential presence of metal particulate matter — Status: Ongoing
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05 — Reason: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. — Status: Ongoing
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88. — Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. — Status: Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922. — Reason: CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. — Status: Ongoing
Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91 — Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. — Status: Ongoing
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-049-88. — Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. — Status: Ongoing
Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01 — Reason: CGMP Deviations: Potential presence of metal particulate matter — Status: Ongoing
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91 — Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. — Status: Ongoing
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-048-88. — Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. — Status: Ongoing
Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. — Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. — Status: Ongoing
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Special
Product code: JXG. Advisory committee: Neurology. Type: Traditional
Product code: MEH. Advisory committee: Orthopedic. Type: Traditional
Product code: IMJ. Advisory committee: Physical Medicine. Type: Traditional
Product code: GZL. Advisory committee: Neurology. Type: Traditional
Product code: SFL. Advisory committee: MG. Decision: APPR
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. — Reason: Product testing did not meet expected stability criteria. — Status: Ongoing
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System — Reason: Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling. — Status: Ongoing
Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: PHATHOM. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: PH HEALTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: HERITAGE PHARMA. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA PHARMS INC. Form: POWDER. Route: SUBCUTANEOUS
Sponsor: TEVA PHARMS INC. Form: POWDER. Route: SUBCUTANEOUS
Sponsor: SANDOZ. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION
Sponsor: STERISCIENCE. Form: INJECTABLE. Route: INJECTION
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: AMNEAL. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: HERITAGE PHARMA. Form: TABLET. Route: ORAL
Sponsor: INVAGEN PHARMS. Form: TABLET. Route: ORAL
Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: IZF. Advisory committee: Radiology. Type: Traditional