Compounded Drugs

Incorrect Product Formulation

Subpotent drug

cGMP Deviations

Subpotent Drug

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.

Lack of Assurance of Sterility.

Lack of Processing Controls.

Lack of Processing Controls.

Lack of Processing Controls.

Lack of Processing Controls.

Lack of Processing Controls.

Lack of Processing Controls.

Lack of Processing Controls.

Lack of Processing Controls.

Lack of Processing Controls.

Lack of Processing Controls.

Lack of Processing Controls.

Lack of Processing Controls.

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

cGMP deviations and lack of assurance of sterility.

cGMP deviations and lack of assurance of sterility.

cGMP deviations and lack of assurance of sterility.

cGMP deviations and lack of assurance of sterility.

cGMP deviations and lack of assurance of sterility.

Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.

Chemical contamination: presence of benzene

Subpotent Drug

Subpotent Drug

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.

Lack of Assurance of Sterility

Non-Sterility

This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

Subpotent Drug

Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Non-Sterility

Non-Sterility

Non-Sterility

Non-Sterility

Non-Sterility

Non-Sterility

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.

Lack of assurance of sterility:

Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Lack of assurance of sterility: Lack of validation data for sanitization cycles

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

CGMP Deviation: impurities exceed allowable limits.

CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.

Chemical Contamination: FDA testing found Presence of methanol

Chemical Contamination: FDA testing found Presence of methanol

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications

Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.

CGMP DEVIATIONS