Breckenridge Pharmaceutical Alprazolam Tablets, USP, 1 mg, CIV recall — FDA D-0460-2023
CGMP Deviations: Potential risk of Cross Contamination
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10,685 detailed records are currently available in this category.
CGMP Deviations: Potential risk of Cross Contamination
CGMP Deviations: Potential risk of Cross Contamination
CGMP Deviations: Potential risk of Cross Contamination
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
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.
CGMP Deviations: Potential risk of Cross Contamination
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Non-Sterility
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
CGMP Deviations: recalling drug products following an FDA inspection.
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of…
CGMP Deviations: recalling drug products following an FDA inspection.
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