Class II · Moderate risk Terminated
Minivelle
Reason Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Minivelle
Reason Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class II · Moderate risk Terminated
Minivelle
Reason Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class III · Low risk Terminated
Bupropion Hydrochloride ER Tablets
Reason 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 Terminated
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter…
Reason cGMP Deviation
Class III · Low risk Terminated
Pramipexole dihydrochloride extended release tablets
Reason Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Class II · Moderate risk Terminated
Synjardy
Reason Cross Contamination With Other Products:
Class II · Moderate risk Terminated
Tizanidine HCl Tablets
Reason Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Class II · Moderate risk Terminated
Arthritis Pain Relief Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Colds & Flu Response Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Allergy & Hay Fever Relief Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Muscle & Joint Pain Relief Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Diarrhea Response Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Sore Throat & Laryngitis Response Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Sinus Response Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Skin Irritation & Itch Response Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel
Reason 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 Terminated
Thyroid powder
Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class III · Low risk Terminated
Argatroban Injection
Reason Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Class II · Moderate risk Terminated
Thyroid
Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk Terminated
Thyroid
Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk Terminated
Thyroid
Reason CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class III · Low risk Terminated
MethylPREDNISolone Tablets
Reason Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Class I · High risk Terminated
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection
Reason Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Class III · Low risk Terminated
Levonorgestrel and Ethinyl Estradiol Tablets
Reason Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.