Class II · Moderate risk
Venlafaxine HCL ER Capsule USP
Failed Dissolution Specifications: out of specification dissolution results in retained samples
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.
14,543 recalls, newest first.
Class II · Moderate risk
Venlafaxine HCL ER Capsule USP
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Class II · Moderate risk
Bactroban Ointment
Penicillin Cross Contamination
Class II · Moderate risk
Bactroban Nasal
Penicillin Cross Contamination
Class II · Moderate risk
Bactroban Cream
Penicillin Cross Contamination
Class II · Moderate risk
Bactroban Cream
Penicillin Cross Contamination
Class II · Moderate risk
Trokendi XR
Superpotent Drug: Failure of assay specifications in the capsule.
Class II · Moderate risk
Dextroamphetamine Sulfate Extended-Release Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Acetylcyst 10% OPHT SOL
Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
Class II · Moderate risk
Metronidazole 500mg Tablet
CGMP Deviations
Class II · Moderate risk
Doxycycline100mg Tablets
CGMP Deviations
Class II · Moderate risk
Acyclovir 400mg Tablet
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Atorvastatin Calcium 40mg Tablet
CGMP Deviations
Class II · Moderate risk
Acetaminophen 325mg tablets
CGMP Deviations
Class II · Moderate risk
Oxygen Nasal Wash
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Class II · Moderate risk
Dream Body Advanced 400 mg 30 capsules in brown foil packets.
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class II · Moderate risk
Dream Body 450 mg 30 capsules in a plastic screw on top bottle
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class II · Moderate risk
Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on…
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Class II · Moderate risk
Glipizide 2.5 mg Extended-release tablets
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Class II · Moderate risk
TAZORAC (tazarotene)
Failed Content Uniformity Specifications
Class II · Moderate risk
TAZORAC (tazarotene)
Failed Content Uniformity Specifications
Class II · Moderate risk
Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection
Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
Class II · Moderate risk
TESTOSTERONE CYPIONATE 200mg/ml
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers.
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Superpotent drug: Out of specification test result for assay during stability testing.