Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339
Midlab Incorporated
cGMP Deviations: Out of specification results for micro in hand soap products.
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Midlab Incorporated
cGMP Deviations: Out of specification results for micro in hand soap products.
Midlab Incorporated
cGMP Deviations: Out of specification results for micro in hand soap products.
Unexo Life Sciences Private Limited
cGMP Deviations
Unexo Life Sciences Private Limited
cGMP Deviations
CGMP violations.
Unexo Life Sciences Private Limited
cGMP Deviations
Unexo Life Sciences Private Limited
cGMP Deviations
Unexo Life Sciences Private Limited
cGMP Deviations
CGMP violations.
The Harvard Drug Group LLC
Failed Impurity/Degradation Specifications
The Harvard Drug Group LLC
Failed Impurity/Degradation Specifications
Safecor Health
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
CGMP Deviations
Zhejiang Jingwei Pharmaceutical Co.
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Supercore Products Group
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Glenmark Pharmaceuticals Inc., USA
Defective Delivery System: The dip tube is clogged causing the spray not to work.
EnviroServe Chemicals
CGMP deviations