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7,990 catalysts · 3,350 8k filing · 1,368 grant · 1,000 device adverse event · 615 approval · 582 earnings · 476 device 510k
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7,990 catalysts · 3,350 8k filing · 1,368 grant · 1,000 device adverse event · 615 approval · 582 earnings · 476 device 510k
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
Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02 — Reason: CGMP Deviations — Status: Ongoing
Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01 — Reason: CGMP Deviations — Status: Ongoing
Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054 — Reason: Failed Dissolution Specifications — Status: Ongoing
Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00. — Reason: CGMP Deviations — Status: Ongoing
Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01 — Reason: CGMP Deviations — Status: Ongoing
Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box, Manufactured for Medique Products, Fort Meyers, FL, 33967, NDC 47682-122-33. — Reason: CGMP Deviations — Status: Ongoing
Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1 — Reason: CGMP Deviations — 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 Manufacturer: 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
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, 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 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17 — 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
MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7 — Reason: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil — Status: Ongoing
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93. — Reason: Failed Dissolution Specifications — Status: Ongoing
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID. — Reason: Presence of Particulate Matter: Due to production issues — Status: Ongoing
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054 — Reason: Failed Dissolution Specifications — Status: Ongoing
Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73 — Reason: CGMP Deviations — Status: Ongoing
Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11 — Reason: Failed Dissolution Specifications — Status: Ongoing
Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00. — Reason: CGMP Deviations — Status: Ongoing
WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01. — Reason: CGMP Deviations — Status: Ongoing
1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Touchpoint, 1000 ea Bulk, Made in USA for : Food Service Resources, Flowery Branch, GA 30542. NDC 0924-7130-00. 3) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Wellstar Cobb Hand Wipes, 1000 ea Bulk, Made in the USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 4) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" FSR Sanitizing Hand Wipes, 1000 ea Bulk, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. Inner Packaging - Instant Hand Sanitizing Wipes 5) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x7" Children's 1000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542 NDC 0924-713-00. Inner packaging -Children's Healthcare of Atlanta — Reason: CGMP Deviations — Status: Ongoing
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054. — Reason: Failed Dissolution Specifications — Status: Ongoing
Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00 — Reason: CGMP Deviations — Status: Ongoing
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China — Reason: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. — Status: Ongoing
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: DWF. Advisory committee: Cardiovascular. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: IZL. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPW. Advisory committee: CV. Decision: OK30