Class II · Moderate risk Completed
QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300…
Reason Lack of assurance of sterility.
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Class II · Moderate risk Completed
Zonisamide Capsules
Reason cGMP deviations
Class II · Moderate risk Completed
Zonisamide Capsules
Reason cGMP deviations
Class II · Moderate risk Completed
Zonisamide Capsules USP
Reason cGMP deviations
Class II · Moderate risk Completed
Trulicity
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Class II · Moderate risk Completed
Trulicity
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class I · High risk Completed
Humalog KwikPen
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class II · Moderate risk Completed
Magnesium Hydroxide 1200mg
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk Completed
Milk of Magnesia USP
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk Completed
Acetaminophen Oral Solution
Reason CGMP Deviations: Failure to properly investigate failed microbial testing.
Class I · High risk Completed
Magnesium Hydroxide 1200mg
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Completed
Milk of Magnesia USP
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Completed
SyrSpend SF Suspending Base
Reason Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Class I · High risk Completed
AmericanScreening HAND SANITIZER
Reason Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class I · High risk Completed
Enoxaparin Sodium Injection
Reason Temperature Abuse; temperature excursion during shipping
Class I · High risk Completed
Methocarbamol 500mg Tablet
Reason Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Class II · Moderate risk Completed
Valproic Acid Oral Solution USP
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk Completed
Promethazine With Codeine Oral Solution
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk Completed
Promethazine Syrup Plain
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class I · High risk Completed
X Rated Honey for Men
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Class II · Moderate risk Completed
Compounded Lyophilized AOD-9604
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
BusPIRone Hydrochloride Tablets
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Completed
Kollidon CL-M Crospovidone Ph.Eur.Type B
Reason Cross contamination: the excipient was found to be contaminated with theophylline.
Class I · High risk Completed
Paroex
Reason Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.