Class II · Moderate risk
Gentell Hydrogel Wound Dressing REGULAR
CGMP Deviations
Oxygen
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
CGMP Deviations: Cylinders filled using out of date gauges.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006.
- Recalling firm
- Medical Park Homecare, Inc
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0776-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other cgmp deviation recalls from 2016
All cgmp deviation recalls
Class II · Moderate risk
Gentell Hydrogel Ag Saturated Gauze
CGMP Deviations
Class II · Moderate risk
Torsemide Tablets
CGMP Deviations
Class II · Moderate risk
Torsemide Tablets
CGMP Deviations
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