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7,525 catalysts · 3,350 8k filing · 1,096 grant · 1,000 device adverse event · 580 earnings · 550 approval · 430 device 510k
7,525 catalysts · 3,350 8k filing · 1,096 grant · 1,000 device adverse event · 580 earnings · 550 approval · 430 device 510k
MH grant. $838,378. PI: Marcelo Dietrich
MH grant. $800,667. PI: Matthias Stadtfeld
AR grant. $20,000. PI: Ann W. Silk
MH grant. $49,416. PI: Brenna Duffy
GM grant. $737,152. PI: Kenichi Yokoyama
GM grant. $375,898. PI: Darryl A Wesener
DK grant. $616,107. PI: Sae Takada
GM grant. $1,600,449. PI: Ethan Clark Garner
HL grant. $1,069,072. PI: Yan-Qing Ma
DK grant. $847,068. PI: JENIFER ELIZABETH ALLSWORTH
EB grant. $722,392. PI: Xiaoyue Ni
CA grant. $4,000. PI: Rushika Miriam Perera
Sponsor: HIBROW HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: ENCUBE. Form: GEL, METERED. Route: TRANSDERMAL
Sponsor: STRIDES PHARMA INTL. Form: CAPSULE. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: CAPSULE. Route: ORAL
Sponsor: BIOCON PHARMA. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL
Sponsor: LABORATORIOS GRIFOLS. Form: INJECTABLE. Route: INJECTION
Sponsor: ALEMBIC. Form: CAPSULE, DELAYED RELEASE. Route: ORAL
Sponsor: ALEMBIC. Form: CAPSULE, DELAYED RELEASE. Route: ORAL
Sponsor: ABBVIE. Form: IMPLANT. Route: INTRAVITREAL
Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: SAVIOR LIFETEC CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: SAVIOR LIFETEC CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: SAVIOR LIFETEC CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: AYRMID PHARMA. Form: POWDER. Route: SUBCUTANEOUS
Sponsor: GLAND. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17 — Reason: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. — Status: Ongoing
Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01. — Reason: CGMP Deviations — Status: Ongoing
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04. — Reason: CGMP Deviations — Status: Ongoing
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06. — Reason: Defective container; inadequately sealed blister packaging. — Status: Ongoing
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China. — Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution — Status: Ongoing
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51. — Reason: Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing — Status: Ongoing
First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00. — Reason: CGMP Deviations — Status: Ongoing
Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01. — Reason: CGMP Deviations — Status: Ongoing
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03. — Reason: CGMP Deviations — Status: Ongoing
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016. — Reason: Stability Data Does Not Support Expiry Date. — Status: Ongoing
MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015. — Reason: Stability Data Does Not Support Expiry Date. — Status: Ongoing
Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr., Stelton, CT 06484, NDC 0924-0243-01. — Reason: CGMP Deviations — Status: Ongoing
Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02 — Reason: CGMP Deviations — Status: Ongoing
Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0 — Reason: Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule). — Status: Ongoing
Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04. — Reason: Lack of Assurance of Sterility — Status: Ongoing
BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02. — Reason: CGMP Deviations — Status: Ongoing
Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00 — Reason: CGMP Deviations — Status: Ongoing
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014. — Reason: Stability Data Does Not Support Expiry Date. — Status: Ongoing
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04 — Reason: CGMP Deviations — Status: Ongoing