Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride
Defective container
18,003 recalls, newest first
Defective container
Defective container
Defective container
Defective container
Labeling: Label Mix-Up
FAILED CONTENT UNIFORMITY SPECIFICATIONS
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Super Potent and Failed Reconstitution Time
Sub Potent
Sub Potent
Super Potent
Sub Potent
Product found to be Sub Potent or Exceeded reconstitution time
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility