Class II · Moderate risk
RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL
Lack of assurance of sterility.
FDA Drug Recalls
360 recalls · Class II, newest first
Class II · Moderate risk
RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL
Lack of assurance of sterility.
Class II · Moderate risk
QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules USP
cGMP deviations
Class II · Moderate risk
Trulicity (dulaglutide)
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Class II · Moderate risk
Trulicity (dulaglutide)
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class II · Moderate risk
Magnesium Hydroxide 1200mg
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Milk of Magnesia USP
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Acetaminophen Oral Solution
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Valproic Acid Oral Solution USP
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine With Codeine Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine Syrup Plain
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Compounded Lyophilized AOD-9604
Lack of Assurance of Sterility
Class II · Moderate risk
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous…
Lack of Assurance of Sterility
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Kollidon CL-M Crospovidone Ph.Eur.Type B
Cross contamination: the excipient was found to be contaminated with theophylline.
Class II · Moderate risk
SYP Health Hand Sanitizer Alcohol Gel
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk
HAND SANITIZER Non-sterile Solution 70% Topical Solution
cGMP deviations
Class II · Moderate risk
Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol
cGMP deviations
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.