Class II · Moderate risk Terminated
Senna 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
14,801 recalls, newest first
Class II · Moderate risk Terminated
Senexon Liquid
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
Diocto Syrup
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
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 III · Low risk Terminated
Claravis
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Mozobil
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-Release Tablets
Reason Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Class III · Low risk Terminated
Mucinex Sinus-Max Day Night
Reason Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
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 III · Low risk Terminated
BuPROPion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Class III · Low risk Terminated
Hydrocortisone and acetic acid otic solution
Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Class III · Low risk Terminated
Acetasol HC
Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
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 I · High risk Terminated
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I
Reason Non-Sterility; microbial contamination identified as Bacillus circulans
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 I · High risk Terminated
Comfort Shield
Reason Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Class II · Moderate risk Terminated
Amikacin Sulfate Injection
Reason CGMP Deviations
Class II · Moderate risk Terminated
Amikacin Sulfate Injection
Reason CGMP Deviations