Drugs & Medicine Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx O...
Failed Dissolution Specifications
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. ...
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drop...
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufac...
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclu...
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x10...
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, ...
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose...
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively ...
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count bo...
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 1...
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufact...
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Re...
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmin...
Presence of Foreign substance - potential presence of metal particulate matter
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham...
Presence of Foreign substance - potential presence of metal particulate matter
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, US...
Lack of Assurance of Sterility
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister c...
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection...
Lack of Assurance of Sterility
Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Hea...
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] pe...
cGMP deviations
ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham...
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria ...
Presence of Foreign substance - potential presence of metal particulate matter
Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmi...
Presence of Foreign substance - potential presence of metal particulate matter
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by U...
Tablets/Capsules Imprinted with Wrong ID