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.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
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.
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.
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.
Class III · Low risk
MethylPREDNISolone Tablets
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Class I · High risk
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Class III · Low risk
Levonorgestrel and Ethinyl Estradiol Tablets
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.