November 7, 2018DrugsFDA
Aurobindo Pharma Limited (Unit I) recalls Irbesartan Bulk Active Pharmaceutical Ingredient.
Hazard: CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
November 7, 2018DrugsFDA
Sprayology recalls Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-00
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-0
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096-002
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 610
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879. NDC 61096
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879NDC 61096-002
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879NDC 61096-0007
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0001
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 6
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-00
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-001
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-00
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-00
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-002
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
November 7, 2018DrugsFDA
Sprayology recalls Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 6
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
October 31, 2018DrugsFDA
Upsher Smith Laboratories, Inc. recalls Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove,
Hazard: Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
October 31, 2018DrugsFDA
Upsher Smith Laboratories, Inc. recalls Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove,
Hazard: Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
October 31, 2018DrugsFDA
Promise Pharmacy LLC recalls Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor,
Hazard: Presence of precipitate
October 31, 2018DrugsFDA
RXQ Compounding LLC recalls Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens
Hazard: Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratori
Hazard: Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratorie
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.