FDA (Drugs) recall action 89938
The FDA (Drugs) publishes a recall like this one as 34 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 34 pages.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Failed Reconstitution time
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.
Olympia Compounding Pharmacy is recalling NAD+ powder vials nationwide because they fail to reconstitute properly. Affected lot F41116 has a beyond-use date of 6/16/2022.
Olympia Compounding Pharmacy recalls 1,871 multi-dose vials of QM-2 injectable medication due to failure to properly investigate manufacturing monitoring excursions prior to October 2021. No illnesses reported.
The FDA is recalling Formula F9, a compounded injectable medication, due to manufacturing control failures. Environmental and personnel monitoring protocols were not properly followed, which could allow contamination.
Olympia Compounding Pharmacy is recalling a multi-drug injectable product nationwide due to manufacturing control deviations. The facility failed to properly investigate environmental and personnel monitoring excursions prior to October 2021.
Olympia Compounding Pharmacy recalls Testosterone Cypionate vials nationwide due to deviations in manufacturing quality monitoring procedures prior to October 2021.
Olympia Pharmaceuticals is recalling approximately 18,060 vials of Sermorelin Acetate distributed nationwide due to manufacturing quality control deviations in which monitoring excursions were not properly investigated. Patients should contact their healthcare provider.
Olympia Compounding Pharmacy is recalling AT-1 injectable medication due to manufacturing control violations. Environmental and personnel monitoring failures may have affected product quality.
Olympia Compounding Pharmacy recalled 1,276 vials of Ultratest testosterone injection nationwide. Prior to October 2021, the manufacturer failed to properly investigate environmental and personnel monitoring deviations per FDA manufacturing standards.
Olympia Compounding Pharmacy is recalling T-50 injectable medication nationwide due to manufacturing quality control failures. Environmental and personnel monitoring controls were not properly investigated prior to October 2021.