Vancomycin Injection
CGMP Deviations
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack Of Processing Controls
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.
Vancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Drug: Vancomycin
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.
CGMP Deviations
CGMP Deviations
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Lack Of Processing Controls
Lack Of Processing Controls
Lack Of Processing Controls
Lack Of Processing Controls
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