FDA (Drugs) recall action 66188
The FDA (Drugs) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Wellness Pharmacy is recalling RL Glutathione 100 mg/mL vials due to laboratory results indicating microbial contamination and concerns about the reliability of testing.
Wellness Pharmacy is recalling 590 vials of Magnesium Sulfate Hepta 50% PF due to laboratory results indicating microbial contamination and concerns about the reliability of testing.
Wellness Pharmacy is recalling 1,355 vials of Dexpanthenol 250 mg/mL due to laboratory results indicating microbial contamination and concerns about the reliability of testing.
Wellness Pharmacy is recalling Phenylbutyrate 200 mg/mL vials because laboratory results indicate microbial contamination and the FDA has concerns about the reliability of the testing data.
Wellness Pharmacy is recalling Methyl B12 1 mg/mL single-use vials because laboratory results indicated microbial contamination and the FDA questioned the reliability of the testing.
Wellness Pharmacy is recalling Dexpanthenol 250mg/ml PF due to laboratory results indicating microbial contamination. The FDA expressed concern that the firm's contract testing lab results may not be reliable.