Class II · Moderate risk
Oxygen
Failed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Oxygen
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
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 MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK
- Recalling firm
- Oklahoma Respiratory Care Inc
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1445-2012 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Oklahoma Respiratory Care Inc
All 2012 recallsOther cgmp deviation recalls from 2012
All cgmp deviation recalls
Class II · Moderate risk
ABILIFY (aripiprazole)
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
Class II · Moderate risk
All Non-Sterile Products manufactured by Ameridose LLC
GMP deficiencies
Class II · Moderate risk
All Non Sterile Products manufactured by NECC
GMP Deviations
Class III · Low risk
Lemon Hand Sanitizing Wipes
CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
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