Class I - Dangerous
Failed Dissolution Specifications
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4
Revive Personal Products Company
Class I - Dangerous
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.
Teva Pharmaceuticals USA
Class I - Dangerous
Lack of Assurance of Sterility
Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00
Rubicon Research Private Limited
Class I - Dangerous
Complaint received of foreign matter (metal) embedded in tablet.
GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech Republic, Distributed by: Perrigo Allergan MI 49010.
Perrigo Company PLC
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed impurities/degradation specifications
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Lupin Pharmaceuticals
Class I - Dangerous
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications