0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC…
Reason Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
1,994 FDA recalls mention Chloride. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Chloride.
Reason Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Reason cGMP deviations.
Reason cGMP deviations.
Reason cGMP deviations.
Reason cGMP deviations.
Reason cGMP deviations.
Reason Subpotent drug
Reason cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Reason cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Reason cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Reason Failed Dissolution Specifications
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability…
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Reason CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Reason Failed tablet specifications.
Reason Crystallization; identified as Buprenorphine free base
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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