| HIS Enterprise Inc dba Adam’s Secret USA, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | ||||
| Optum Infusion Services 308 LLC | Division of Pharmaceutical Quality Operations IV | Compounding Pharmacy/Adulterated Drug Products |
| PharmaCanna | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Purecraft LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |||
| Medical Mikes, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |||
| San-Rey Produce Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||
| Sun Pharmaceutical Industries Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||
| Florida Gold Foods LLC | Division of Human and Animal Food Operations East IV | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||
| Auto-Chlor System LLC | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | |||
| Aizu Olympus Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | |||
| Olympus Medical Systems Corporation | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | |||
| Distributor RFR, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
| pharmahealthonline.com | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet |
Today the U.S. Food and Drug Administration approved DectoGard, the first generic doramectin topical solution for treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, horn flies, and mange mites in cattle.
DectoGard is an antiparasitic drug that contains the same active ingredient (doramectin topical solution) in the same concentration and dosage form as the approved brand name drug product, Dectomax (doramectin topical solution), which was first approved for use in cattle on September 16, 1997. Additionally, data demonstrate that residues in food products derived from cattle treated with DectoGard will not represent a public health concern when the product is used according to the label.
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