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2,579 catalysts · 3,288 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
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2,579 catalysts · 3,288 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
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Sponsor: CSPC OUYI PHARM CO. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: LUPIN LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: HIKMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: STRIDES PHARMA INTL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL
Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION
Sponsor: PHARMACYCLICS LLC. Form: SUSPENSION. Route: ORAL
Sponsor: LUPIN LTD. Form: CAPSULE. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL
Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION
Sponsor: BAUSCH AND LOMB INC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: PHARMACYCLICS LLC. Form: TABLET. Route: ORAL
Sponsor: PH HEALTH. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: INJECTION
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: CAPLIN. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: L PERRIGO CO. Form: TABLET. Route: ORAL
Sponsor: L PERRIGO CO. Form: TABLET. Route: ORAL
Sponsor: L PERRIGO CO. Form: TABLET. Route: ORAL
Sponsor: NOVAST LABS. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: MEITHEAL. Form: POWDER. Route: INTRAVENOUS
Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Form: INJECTABLE. Route: INJECTION
Sponsor: KENVUE BRANDS. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: NOVITIUM PHARMA. Form: TABLET. Route: ORAL
Sponsor: QUAGEN. Form: SOLUTION. Route: ORAL
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 — Reason: Failed Dissolution Specifications — Status: Ongoing
Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01 — Reason: Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg). — Status: Ongoing
Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04. — Reason: Discoloration — Status: Ongoing
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02. — Reason: Labeling: Incorrect or Missing Lot and/or Exp Date — Status: Ongoing
Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. — Reason: Failed Dissolution Specifications — Status: Ongoing
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose] — Reason: CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. — Status: Ongoing
Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30 — Reason: Lack of Assurance of Sterility: — Status: Ongoing
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1 — Reason: Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. — Status: Ongoing
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. — Reason: Failed Dissolution Specifications — Status: Ongoing
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. — Reason: Failed Dissolution Specifications — Status: Ongoing
Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05. — Reason: Labeling: Incorrect or Missing Lot and/or Exp Date — Status: Ongoing
FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05. — Reason: Labeling: Incorrect or Missing Lot and/or Exp Date — Status: Ongoing
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29. — Reason: Failed Impurities/Degradation Specifications — 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
Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344 — Reason: cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing. — Status: Ongoing