Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

201 results found for potency Page 4 of 9
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Children's Ear Relief Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 3579550...
Reason: Microbial contamination
D-0687-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Colic Relief Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955015826, ND...
Reason: Microbial contamination
D-0681-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Children's Fever Reliever Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357...
Reason: Microbial contamination
D-0689-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Attention & Learning Enhancement Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, ...
Reason: Microbial contamination
D-0677-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Lower GI Restoration Digestion High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 3579550...
Reason: Microbial contamination
D-0678-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Lonely Mind & Body High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955200024, NDC...
Reason: Microbial contamination
D-0680-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Hyperactive High Potency Homeopathic Formula, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955151029, NDC 57955-1511-2
Reason: Microbial contamination
D-0975-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Children's Appetite & Weight Control Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 U...
Reason: Microbial contamination
D-0682-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Upper GI Restoration Digestion High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive Asheville, NC 28806 USA, UPC 35795...
Reason: Microbial contamination
D-0698-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Influenza Multi-Strain Flu Medicine Immune High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA,...
Reason: Microbial contamination
D-0679-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Children's Growth & Development Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, U...
Reason: Microbial contamination
D-0684-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Children's Cough Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955014522...
Reason: Microbial contamination
D-0685-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's Natural Medicine Aquaflora Candida High Potency 9 Multi-Strain Candida Formula, 236 mL, (liquid/liquide), Manufactured by:/Fabrique par: King Bio, Inc. 3 Westside Dr., Asheville, NC 28805 U...
Reason: Microbial contamination
D-0962-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Breast Cyst & Discomforts High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955000327, ...
Reason: Microbial contamination
D-0985-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCareRx CS-Lung High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955022626, NDC 57955-0226-2
Reason: Microbial contamination
D-0979-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Soothing Advanced Arnica Pure Homeopathic Cream High Potency Homeopathic Formula for Professional Use Only, 3 oz. (85 g), King Bio, Inc., 3 Westside Drive Asheville, NC 28806 US...
Reason: Microbial contamination
D-0697-2019 March 20, 2019 Asheville, NC
King Bio Inc.
Class I Terminated
Dr. King's SafeCare Rx Aversion to Change High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955280026, NDC 579...
Reason: Microbial contamination
D-0984-2019 March 20, 2019 Asheville, NC
Syntho Pharmaceuticals, Inc.
Class II Terminated
EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwo...
Reason: CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
D-0377-2019 January 23, 2019 Farmingdale, NY
Syntho Pharmaceuticals, Inc.
Class II Terminated
EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Ph...
Reason: CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
D-0378-2019 January 23, 2019 Farmingdale, NY
Validus Pharmaceuticals, Inc.
Class III Terminated
Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
Reason: Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
D-1170-2018 September 5, 2018 Parsippany, NJ
Validus Pharmaceuticals, Inc.
Class III Terminated
Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
Reason: Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
D-1171-2018 September 5, 2018 Parsippany, NJ
Ingenus Pharmaceuticals Llc
Class II Terminated
Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius ...
Reason: Superpotent Drug: High out of specification assay value results for potency.
D-0890-2018 July 11, 2018 Orlando, FL
Ingenus Pharmaceuticals Llc
Class II Terminated
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius P...
Reason: Superpotent Drug: High out of specification assay value results for potency.
D-0891-2018 July 11, 2018 Orlando, FL
Apotex Inc.
Class I Terminated
Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apote...
Reason: Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
D-0840-2018 May 23, 2018 North York
Apotex Inc.
Class I Terminated
Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apo...
Reason: Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
D-0839-2018 May 23, 2018 North York