Class II · Moderate risk Terminated
Diocto Syrup
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Aller-Chlor
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
Ninjacof-A
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
Ninjacof
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
Sennazon
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
Pantoprazole Sodium Delayed-Release Tablets USP
Reason Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
Class II · Moderate risk Terminated
Venlafaxine Hydrochloride Extended-Release Capsules
Reason Failed Dissolution Specifications: Out-of-specification results in retained sample.
Class II · Moderate risk Terminated
Venlafaxine Hydrochloride Extended-Release Capsules
Reason Failed Dissolution Specifications: Out-of-specification results in retained sample.
Class II · Moderate risk Terminated
Zinc Acetate
Reason Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Class II · Moderate risk Terminated
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension
Reason Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.
Class II · Moderate risk Terminated
2% Chlorhexidine Gluconate* Cloth
Reason CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Class II · Moderate risk Terminated
Comfort Shield
Reason CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Class II · Moderate risk Terminated
Amikacin Sulfate Injection
Reason CGMP Deviations
Class II · Moderate risk Terminated
Amikacin Sulfate Injection
Reason CGMP Deviations
Class II · Moderate risk Terminated
C-Pav/Phentol/Atrop/Pge1
Reason Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Class II · Moderate risk Terminated
C-Pav/Phentol/Pge1
Reason Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Class II · Moderate risk Terminated
DMSO 50% with Lidocaine 0.5%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hyaluronidase
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
C-PAP/PHEN/PROST/Atrop 150/7.5
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Olopatadine 0.8% Ophthalmic Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
C-Pap/Phen/Prost/Atrop 150/5/5
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydroxyzine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pre-Op Pledget Soln + Tetracaine
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pre-Op Pledget Soln
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Autologous Serum Tears
Reason Lack of Assurance of Sterility