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Labeling; Incorrect NDC number on outer carton of product.
CGMP Deviations
CGMP Deviations: Discoloration
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Defective Delivery System: Out of specification for shear.
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Failed Impurities/Degradation Specifications
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.