948 recalls · Class II, newest first
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Reason CGMP Deviation: impurities exceed allowable limits.
Reason Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of assurance of sterility: bags have the potential to leak.
Reason Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Reason Presence of Particulate Matter: Particulate matter identified as fiber.
Reason Presence of Particulate Matter: Particulate matter identified as fiber.
Reason Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Reason Failed Stability Specifications
Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Reason CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Reason Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of…
Reason Defective Delivery System
Reason Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Reason Packaging defect: blister packaging inadequately sealed.
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Reason CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Reason cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Reason cGMP deviations
Reason cGMP deviations