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106 catalysts · 36 recall · 24 grant · 16 device recall · 12 device pma · 11 approval · 7 device 510k
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106 catalysts · 36 recall · 24 grant · 16 device recall · 12 device pma · 11 approval · 7 device 510k
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: AJANTA PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: SCIENTURE. Form: SUSPENSION. Route: ORAL
Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL
Sponsor: CHARTWELL RX. Form: CAPSULE. Route: ORAL
Sponsor: AUROBINDO PHARMA. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: RIDGEBACK BIOTHERAPEUTICS. Form: POWDER. Route: IV (INFUSION)
Sponsor: IPCA LABS LTD. Form: CAPSULE. Route: ORAL
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63 — Reason: Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment. — Status: Ongoing
Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11 — Reason: cGMP deviations — Status: Ongoing
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56. — Reason: Lack of Assurance of Sterility — Status: Ongoing
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11 — Reason: Defective container: Multiple customer complaints received for card seal defects observed on the subject lots. Customers reported card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. — Status: Ongoing
Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59. — Reason: Lack of Assurance of Sterility — Status: Ongoing
ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10. — Reason: Tablets/Capsules Imprinted with Wrong ID — Status: Ongoing
Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 100mg, Anastrozole 4mg (4.5), 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-01. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. — Reason: Defective Delivery System: Missing or duplicated needles within the injection kit — Status: Ongoing
Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11 — Reason: cGMP deviations — Status: Ongoing
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32 — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: NBC. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional