| 08/17/2018 | Torrent | Valsartan/Amlodipine/HCTZ Tablets | Impurity detected in the API is N-nitrosodimethylamine (NDMA) | Torrent Pharmaceuticals |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, August 21, 2018
| 08/15/2018 | Healthy Healing dba Crystal Star | Minneapolis District Office | New Drug/Labeling/Misbranded | Not Issued * |
| 08/10/2018 | Kyowa Hakko Bio Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Not Issued * |
| 07/31/2018 | Hangzhou Karic Commodities Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
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