Class II · Moderate risk
Petroleum Jelly
Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Little Remedies Gas Relief Drops
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Class II · Moderate risk
Phenazopyridine HCl Tablets USP
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Class II · Moderate risk
suntegrity
CGMP Deviations
Class II · Moderate risk
Dexamethasone Sodium Phosphate injection USP
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Class II · Moderate risk
Zoledronic Acid Injection 5mg/100mL Sterile Solution
Lack of Assurance of Sterility: Leaking vials
Class II · Moderate risk
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Class II · Moderate risk
Extra Strength Acetaminophen 500 MG Tablets
Discoloration: Brownish tablets
Class II · Moderate risk
Labetalol Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk
Buprenorphine Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II · Moderate risk
Cathflo activase
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
Eylea
Lack of Assurance of Sterility: Complaints of syringe breakage
Class II · Moderate risk
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Klarity-C (cyclosporine)
Lack of Assurance of Sterility
Class II · Moderate risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials…
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use…
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone-Moxifloxacin- Ketorolac
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone-Moxifloxacin
Lack of Assurance of Sterility
Class II · Moderate risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Lack of Assurance of Sterility
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Class II · Moderate risk
Rizatriptan Benzoate Orally Disintegrating Tablets
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk
Rizatriptan Benzoate Orally Disintegrating Tablets
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.