Class I - Dangerous
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
💊
Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class I - Dangerous
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.
Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Class I - Dangerous
Presence of Foreign substance - potential presence of metal particulate matter
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
Pro Numb Tattoo Numbing Spray
Class I - Dangerous
cGMP deviations
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.
Fresenius Kabi Compounding
Class I - Dangerous
Lack of Assurance of Sterility
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
Fresenius Kabi Compounding
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Class I - Dangerous
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Class I - Dangerous
Presence of Foreign substance - potential presence of metal particulate matter
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Class I - Dangerous
Presence of Foreign substance - potential presence of metal particulate matter
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
Fresenius Kabi Compounding
Class I - Dangerous
Lack of Assurance of Sterility
Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Class I - Dangerous
Presence of Foreign substance - potential presence of metal particulate matter
ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Class I - Dangerous
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Class I - Dangerous
Presence of Foreign substance - potential presence of metal particulate matter
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.
Fresenius Kabi Compounding
Class I - Dangerous
Lack of Assurance of Sterility
ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Class I - Dangerous
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Class I - Dangerous
Presence of Foreign substance - potential presence of metal particulate matter
Class I - Dangerous
Tablets/Capsules Imprinted with Wrong ID
Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1012-32.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Class I - Dangerous
Presence of Foreign substance - potential presence of metal particulate matter