PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile…
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
501 FDA recalls mention Methyl. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Methyl.
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Reason Lack of Assurance of Sterility
Reason Lack of assurance of sterility.
Reason Defective Delivery System: customer complaints exceeded respective action limits.
Reason Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of…
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason Subpotent
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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