Class II · Moderate risk
Ephedrine Sulfate Injection
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
FDA Drug Recalls
1,103 recalls, newest first
Class II · Moderate risk
Senna Syrup
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
Senexon Liquid
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
Diocto Syrup
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
Aller-Chlor
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
Ninjacof-A
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
Ninjacof (chlophedianol HCl and pyrilamine maleate)
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
Sennazon (sennosides)
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
Claravis (isotretinoin capsules USP)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Mozobil (plerixafor injection)
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Class III · Low risk
Mucinex Sinus-Max Day Night
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
Pantoprazole Sodium Delayed-Release Tablets USP
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
Venlafaxine Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Class III · Low risk
Hydrocortisone and acetic acid otic solution
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
Acetasol HC
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
Zinc Acetate
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Class II · Moderate risk
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension
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
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I
Non-Sterility; microbial contamination identified as Bacillus circulans
Class II · Moderate risk
2% Chlorhexidine Gluconate* Cloth
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Class II · Moderate risk
Comfort Shield
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Class I · High risk
Comfort Shield
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Class II · Moderate risk
Amikacin Sulfate Injection
CGMP Deviations