Lack of Processing Controls.
Compounded Drugs
💊 Drugs • 1,855 recalls
Lack of Processing Controls.
Lack of Processing Controls.
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
cGMP deviations and lack of assurance of sterility.
cGMP deviations and lack of assurance of sterility.
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.
BRS Analytical Services
cGMP deviations and lack of assurance of sterility.
cGMP deviations and lack of assurance of sterility.
cGMP deviations and lack of assurance of sterility.
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
Fruit Of The Earth
Chemical contamination: presence of benzene
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30.
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01.
Wuxi Medical lnstrument Factory Co.
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
Fagron Compounding Services
Lack of Assurance of Sterility
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Alcon Research
Non-Sterility
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Subpotent Drug
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.