Class II · Moderate risk
Ascorbic Acid 500 mg/mL Solution Pharm D Solutions
Lack of Assurance of Sterility
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Arginine Injections 100 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Acetylcysteine Injection 10 mg/5 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Actoplus met XR
Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class III · Low risk
Bupropion Hydrochloride ER Tablets
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Class II · Moderate risk
Class III · Low risk
Pramipexole dihydrochloride extended release tablets
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Class II · Moderate risk
Synjardy (empagliflozin and metformin hydrochloride)
Cross Contamination With Other Products:
Class II · Moderate risk
Tizanidine HCl Tablets
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Class II · Moderate risk
Arthritis Pain Relief Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Colds & Flu Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Allergy & Hay Fever Relief Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Muscle & Joint Pain Relief Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Diarrhea Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Sore Throat & Laryngitis Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Sinus Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
Skin Irritation & Itch Response Homeopathic Formula
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk
NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel
CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.
Class II · Moderate risk
Thyroid powder
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class III · Low risk
Argatroban Injection
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Class II · Moderate risk
Thyroid
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.