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1,132 catalysts · 18,987 approval · 5,000 device 510k · 4,779 phase readout · 4,728 grant · 2,387 8k filing · 2,000 device pma
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1,132 catalysts · 18,987 approval · 5,000 device 510k · 4,779 phase readout · 4,728 grant · 2,387 8k filing · 2,000 device pma
PEPCID COMPLETE - 25CT — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
DAYQUIL COLD & FLU, 32CT/2PK — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Benadryl, 25'S 2PK Box, UPC 815556020316 — Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. — Status: Ongoing
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4 — Reason: Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. — Status: Ongoing
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39 — Reason: Failed PH Specifications — Status: Ongoing
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02 — Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. — Status: Ongoing
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01 — Reason: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. — Status: Ongoing
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
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07 — Reason: Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients. — Status: Ongoing
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10. — Reason: Presence of Foreign Substance — Status: Ongoing
Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02 — Reason: Subpotent Drug — Status: Ongoing
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02. — Reason: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution — Status: Ongoing
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72 — Reason: Failed Impurities/Degradation Specifications — Status: Ongoing
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2 — Reason: Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil. — Status: Ongoing
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01 — Reason: Failed Disintegration Specifications: above the time expected. — Status: Ongoing
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 — Reason: Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil — Status: Ongoing
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01. — Reason: Presence of Foreign Tablets/Capsules — Status: Ongoing
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7 — Reason: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. — Status: Ongoing
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313 — Reason: CGMP Deviations: product found to contain lead. — 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