Drug recalls
500 recallsSILINTAN 25/pills, packaged in a 25-count bottle
ANTHONY TRINH, 123Herbals LLC
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
BioGlo Fluorescein Sodium Ophthalmic Strips USP
Wizcure Pharmaa Private Limited
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g…
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Wizcure Pharmaa Private Limited
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g…
Vista Tears Polyethylene Glycol 400 0.4% w/v
Wizcure Pharmaa Private Limited
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g…
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus…
Slate Run Pharmaceuticals
Labeling: Not Elsewhere Classified.
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose
AvKARE
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification…
Vista Gel Hypromellose USP 0.3% w/v
Wizcure Pharmaa Private Limited
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g…
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL
LEO PHARMA INC
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lo…
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (St…
Wizcure Pharmaa Private Limited
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g…
Agebox iKids-Growth (Night Formula), 60-count bottles
Agebox
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry…
Wizcure Pharmaa Private Limited
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g…
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles
Agebox
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg
Wizcure Pharmaa Private Limited
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g…
UDENYCA, pegfilgrastim-cbqv injection
McKesson
Temperature Abuse.
Testosterone, 100 mg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
Pro Numb Tattoo Numbing Spray, 5% Lidocaine
Pro Numb Tattoo Numbing Spray LLC
cGMP deviations
thiamine HCl, 500 mg, 500 mg added to 100 mL
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodiu…
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg
Amerisource Health Services LLC
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling…
Testosterone, 200 mg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone, 25.0 mg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
Testosterone, 87.5 mg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
vancomycin HCl, 2 grams, 2 grams added to 500 mL
Fresenius Kabi Compounding, LLC
Lack of Assurance of Sterility
ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone, 62.5 mg, 1 Sterile Pellet
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Presence of Foreign substance - potential presence of metal particulate matter
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only
Unichem Pharmaceuticals USA Inc.
Tablets/Capsules Imprinted with Wrong ID