Class II · Moderate risk
Formula F9
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
FDA Drug Recalls
1,018 recalls, newest first
Class II · Moderate risk
T-105
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60…
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Sermorelin Acetate
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Esomeprazole Magnesium Delayed-Release Capsules
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Class II · Moderate risk
Esomeprazole Magnesium Delayed-Release Capsules
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Class III · Low risk
Methylprednisolone Tablets
Subpotent
Class II · Moderate risk
Travoprost Ophthalmic Solution
Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
Class III · Low risk
23.4% Sodium Chloride Injection
Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Janumet (sitagliptin and metformin HCl)
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Class I · High risk
The Mandalorian Hand Sanitizer
Chemical Contamination; FDA analysis found product to contain benzene
Class I · High risk
Mickey Mouse Hand Sanitizer
Chemical Contamination; FDA analysis found product to contain methanol
Class III · Low risk
Wal-Tussin DM
Incorrect/Undeclared Excipient: Product contains alcohol
Class I · High risk
Pink Pussycat SENSUAL ENHANCEMENT capsule
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
IDArubicin Hydrochloride Injection USP 5gm/5mL
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Class II · Moderate risk
Preferred Pharmaceuticals
Out of specification results observed in dissolution during long term stability testing.