Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0685-2016 | 01-15-2016 | methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 22 ml | Class II | Terminated |
| D-0692-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0677-2016 | 01-15-2016 | calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 200 ml | Class II | Terminated |
| D-0698-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 5 ml | Class II | Terminated |
| D-0707-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 40 ml | Class II | Terminated |
| D-0683-2016 | 01-15-2016 | hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 20 ml | Class II | Terminated |
| D-0708-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 5 ml | Class II | Terminated |
| D-0718-2016 | 01-15-2016 | papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 20 ml | Class II | Terminated |
| D-0684-2016 | 01-15-2016 | Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0688-2016 | 01-15-2016 | papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 5 ml | Class II | Terminated |
| D-0676-2016 | 01-15-2016 | Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 7200 mL | Class II | Terminated |
| D-0711-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 5 ml | Class II | Terminated |
| D-0680-2016 | 01-15-2016 | Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 6 ml | Class II | Terminated |
| D-0697-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0716-2016 | 01-15-2016 | testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 36 ml | Class II | Terminated |
| D-0715-2016 | 01-15-2016 | progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0709-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0690-2016 | 01-15-2016 | papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 30 ml | Class II | Terminated |
| D-0686-2016 | 01-15-2016 | methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 41 ml | Class II | Terminated |
| D-0701-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 25 ml | Class II | Terminated |
| D-0775-2016 | 01-15-2016 | Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL | Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate). | Virtus Pharmaceuticals, Llc / 1,139 bottles total | Class III | Terminated |
| D-0704-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 5 ml | Class II | Terminated |
| D-0710-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 35/1.2 mg/20 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0695-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0679-2016 | 01-15-2016 | Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 30 ml | Class II | Terminated |
| D-0712-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 10 ml | Class II | Terminated |
| D-0696-2016 | 01-15-2016 | papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705 | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance. | Abbott's Compounding Pharmacy, Inc. / 5 ml | Class II | Terminated |
| D-0725-2016 | 01-14-2016 | risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06. | Failed Impurities/Degradation Specifications: Out of specification for a known degradant. | Zydus Pharmaceuticals USA Inc / 9504 Bottles | Class III | Terminated |
| D-0649-2016 | 01-11-2016 | Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68 Package NDCs: 0071-1012-68; 0071-1013-41; 0071-1013-68; 0071-1014-41; 0071-1014-68; 0071-1015-41; 0071-1015-68; 0071-1016-41; 0071-1016-68; 0071-1017-68; 0071-1019-68; 0071-1018-68; 0071-1020-01 | FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. | Pfizer Inc. / 116,400 bottles | Class II | Terminated |
| D-0648-2016 | 01-11-2016 | Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68 Package NDCs: 0071-1012-68; 0071-1013-41; 0071-1013-68; 0071-1014-41; 0071-1014-68; 0071-1015-41; 0071-1015-68; 0071-1016-41; 0071-1016-68; 0071-1017-68; 0071-1019-68; 0071-1018-68; 0071-1020-01 | FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. | Pfizer Inc. / 30,672 bottles | Class II | Terminated |
| D-0897-2016 | 01-09-2016 | Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / 240 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0888-2016 | 01-09-2016 | Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0903-2016 | 01-09-2016 | Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0907-2016 | 01-09-2016 | Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0904-2016 | 01-09-2016 | Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / 100 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0900-2016 | 01-09-2016 | Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0891-2016 | 01-09-2016 | Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsules),Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0885-2016 | 01-09-2016 | Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0890-2016 | 01-09-2016 | Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0884-2016 | 01-09-2016 | Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0905-2016 | 01-09-2016 | Samurai-X, packaged in BIG BOX (24 individually wrapped capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0887-2016 | 01-09-2016 | Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0894-2016 | 01-09-2016 | Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0889-2016 | 01-09-2016 | African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0906-2016 | 01-09-2016 | Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0892-2016 | 01-09-2016 | Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0893-2016 | 01-09-2016 | African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0895-2016 | 01-09-2016 | Black Ant King, packaged in BIG BOX (10 capsules / can / 12 cans per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0901-2016 | 01-09-2016 | Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0886-2016 | 01-09-2016 | Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0898-2016 | 01-09-2016 | Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0899-2016 | 01-09-2016 | Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0896-2016 | 01-09-2016 | Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0902-2016 | 01-09-2016 | Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467 | Marketed Without An Approved NDA/ANDA | R Thomas Marketing, LLC / unknown | Class I | Terminated |
| D-0587-2016 | 01-08-2016 | Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: McKesson, San Francisco, CA 94104, NDC 49348-828-34; b) Rite-Aid, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Rite-Aid, Camp Hill, PA 17011, NDC 11822-0419-1; c) Topcare, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-419-26; d) Kroger, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: The Kroger Co., Cincinnati, OH 46202, NDC 30142-419-26; e) GoodSense, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: Perrigo, Allegan, MI 49010, NDC 0113-0419-26; f) Dollar General, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: DolgenCorp, LLC, Goodlettsville, TN 37072, NDC 55910-419-26; g) Care One, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Gluten Free, Distributed by: American Sales Company, Lancaster, NY 14086, NDC 41520-419-26; h) CVS, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: CVS Pharmacy Inc, Woonsocket, RI 02895. | Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups. | Perrigo Company PLC / N/A | Class II | Terminated |
| D-0586-2016 | 01-08-2016 | Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for: H.E.B. San Antonio, TX 78204, NDC 37808-288-26; b) CVS, Children's Mucus Relief Chest Congestion, Guaifenesin, Expectorant, Alcohol free, Gluten free, 4 FL OZ (118 mL) Bottle, For Ages 4 to 12 Years, Grape Flavor Liquid, Dosage Cup Included, Distributed by CVS Pharmacy Inc, One CVS Drive, Woonsocket, RI, 02895, NDC 59779-288-26. | Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups. | Perrigo Company PLC / N/A | Class II | Terminated |
| D-0668-2016 | 01-05-2016 | Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24. Package NDCs: 0409-6730-11; 0409-6730-13; 0409-6730-50; 0409-6730-60; 0409-6729-41; 0409-6729-23; 0409-6729-21; 0409-6729-03; 0409-6729-31; 0409-6729-09; 0409-6729-11; 0409-6729-24; 0409-4121-01; 0409-4121-50; 0409-2050-01; 0409-2050-20; 0409-3164-01; 0409-3164-12; 0409-5239-01; 0409-5239-60 | Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium. | Hospira Inc. / 213,600 bags | Class I | Terminated |
| D-0585-2016 | 01-05-2016 | Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 | Lack of Assurance of Sterility: Failed preservative effectiveness test | Mayne Pharma Usa / a) 52034 bottles and b) 22074 bottles | Class II | Terminated |
| D-0659-2016 | 12-31-2015 | Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540 | Failed Impurities/Degradation Specifications; 9 month stability timepoint | Sandoz Inc / 277,267 bottles | Class III | Terminated |
| D-0777-2016 | 12-31-2015 | NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61 | Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration | Pharmedium Services, LLC / 6,816 bags | Class III | Terminated |
| D-0778-2016 | 12-31-2015 | NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61 | Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration | Pharmedium Services, LLC / | Class III | Terminated |
| D-0733-2016 | 12-29-2015 | Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023 | Lack of assurance of sterility | TexasStar Pharmacy / 700 mL (7 vials of 100 mL) | Class II | Terminated |
| D-0917-2017 | 12-29-2015 | Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014 | Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture. | Complete Pharmacy and Medical Solutions LLC / 1890 syringes | Class I | Ongoing |
| D-0570-2016 | 12-24-2015 | IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614 | Lack of Assurance of Sterility | Amerita Specialty Infusion Services / 1 syringe | Class II | Terminated |
| D-0569-2016 | 12-24-2015 | Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614 | Lack of Assurance of Sterility | Amerita Specialty Infusion Services / 1 syringe | Class II | Terminated |
| D-0653-2016 | 12-24-2015 | Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10. Package NDCs: 33342-031-10; 33342-031-15; 33342-031-06; 33342-031-12; 33342-032-10; 33342-032-15; 33342-032-06; 33342-032-12; 33342-033-10; 33342-033-15; 33342-033-06; 33342-033-12; 33342-034-10; 33342-034-15; 33342-034-06; 33342-034-12; 33342-035-10; 33342-035-15; 33342-035-06; 33342-035-12 | Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet. | Macleods Pharma Usa Inc / N/A | Class II | Terminated |
| D-0021-2017 | 12-23-2015 | Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein | Bee Xtreme / 13 bottles | Class I | Terminated |
| D-0020-2017 | 12-23-2015 | Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein | Bee Xtreme / 732 bottles | Class I | Terminated |
| D-0019-2017 | 12-23-2015 | La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein | Bee Xtreme / 589 bottles | Class I | Terminated |
| D-0667-2016 | 12-23-2015 | APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7. | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug. | Nuway Distributors, LLC / 100,000 blister cards | Class I | Ongoing |
| D-0578-2016 | 12-22-2015 | Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Shingles Pain & Ulceration Relief Topical Homeopathic Spray, NDC 50845-0215-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Shingles Pain & Ulceration Relief, homeopathic spray, UPC 8 18692 00875 0, NDC 43845-0044-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA | Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count | Grato Holdings, Inc. / 371 bottles | Class II | Terminated |
| D-0576-2016 | 12-22-2015 | Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0132-1, Dist. by Energique, Inc. Woodbine, IA 51579; ALSO LABELED AS --- Liddell Laboratories, Muscle/Tendon Pain & Stress Relief, Topical Homeopathic Spray, NDC 50845-0219-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Muscle/Tendon Pain & Stress Relief, homeopathic spray, UPC 8 18692 00870 5, NDC 43846-0043, Dist. by Peaceful Mountain, Inc. Woodbine, IA | Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count | Grato Holdings, Inc. / 201 bottles | Class II | Terminated |
| D-0579-2016 | 12-22-2015 | Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Headache Pain & Sinus Pressure Relief, Topical Homeopathic Spray, NDC 50845-0217-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Headache Pain & Sinus Pressure Relief, homeopathic spray, UPC 8 18692 00885 9, NDC 43846-0041-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA | Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count | Grato Holdings, Inc. / 90 bottles | Class II | Terminated |
| D-0575-2016 | 12-22-2015 | Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, skin irritant & healing support, homeopathic spray, UPC 8 18692 00880 4, NDC 43846-0046-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA | Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count | Grato Holdings, Inc. / 118 bottles | Class II | Terminated |
| D-0577-2016 | 12-22-2015 | Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Joint Pain & Stiffness Relief, Topical Homeopathic Spray, NDC 50845-0218-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Joint Pain & Stiffness Relief, homeopathic spray, UPC 8 18692 00890 3, NDC 43846-0042-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA | Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count | Grato Holdings, Inc. / 224 bottles | Class II | Terminated |
| D-0580-2016 | 12-22-2015 | Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, First Aid Pain & Trauma Relief, Topical Homeopathic Spray, NDC 50845-0216-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, First Aid Pain & Trauma Relief, homeopathic spray, UPC 8 18692 00895 8, NDC 43846-0045-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA | Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count | Grato Holdings, Inc. / 118 bottles | Class II | Terminated |
| D-0732-2016 | 12-21-2015 | Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89 Package NDCs: 0093-7473-06; 0093-7474-89 | Failed Dissolution Specifications: low test results at the 18 month time-point | Teva North America / 1,895 bottles | Class II | Terminated |
| D-1440-2016 | 12-21-2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 12285 boxes | Class II | Terminated |
| D-1438-2016 | 12-21-2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 7850 boxes | Class II | Terminated |
| D-1439-2016 | 12-21-2015 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration. | Noven Pharmaceuticals, Inc. / 2088 boxes | Class II | Terminated |
| D-0568-2016 | 12-18-2015 | Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01 | Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg. | National Vitamin Co Inc / 29,827 bottles | Class III | Terminated |
| D-0801-2016 | 12-17-2015 | VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305 | Defective Delivery System: Product may contain leaking capsules. | Virtus Pharmaceuticals, Llc / 688 bottles ( 20,640 softgel capsules) | Class III | Terminated |
| D-0809-2016 | 12-17-2015 | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51 | Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing. | Bio-pharm, Inc. / 103,664 Bottles | Class III | Terminated |
| D-1142-2016 | 12-15-2015 | Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104 | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / 79 bottles | Class I | Terminated |
| D-1140-2016 | 12-15-2015 | EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E. Atlantic Blvd, Pompano Beach, Florida, 33062 WWW.BEEEXTREMELYAMAZED.COM | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1149-2016 | 12-15-2015 | XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1143-2016 | 12-15-2015 | La' Trim Plus Capsules, 350 mg, 60-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando, FL 32801 (407) 930-4043 | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1147-2016 | 12-15-2015 | SLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1150-2016 | 12-15-2015 | XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1139-2016 | 12-15-2015 | Asset extreme+PLUS Capsules, 500 mg, 30-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com www.allnaturalbeelievers.com | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1144-2016 | 12-15-2015 | Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando FL 32801 (407)930-4043 | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / 581 bottles | Class I | Terminated |
| D-1146-2016 | 12-15-2015 | SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceuticals Ltd. MUMBAI-400-030 Manufactured in India by: HAB Pharmaceuticals & Research Limited 10-Pharma City, SIDCUL, Selaqui, Dehradun, 248 197 | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1145-2016 | 12-15-2015 | Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. #392 Columbus, IN 47203 | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / 1,104 bottles | Class I | Terminated |
| D-1151-2016 | 12-15-2015 | ZI XIU TANG BEAUTY FACE & FIGURE Capsules, 250 mg, 60-count bottles | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1138-2016 | 12-15-2015 | Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1141-2016 | 12-15-2015 | Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-1148-2016 | 12-15-2015 | Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu Tang Success, LLC Trexlertown, PA 18087, USA www.zixiutangsuccess.com | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug. | Bee Extremely Amazed LLC / N/A | Class I | Terminated |
| D-0958-2016 | 12-15-2015 | Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06 Package NDCs: 0338-0719-06 | Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product. | Baxter Healthcare Corp. / 28,080 VIAFLEX Plastic Containers | Class I | Terminated |
| D-0957-2016 | 12-15-2015 | 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product. | Baxter Healthcare Corp. / 255,852 VIAFLEX Plastic Containers | Class I | Terminated |
| D-0571-2016 | 12-15-2015 | Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60 | Super-Potent Drug: Out of Specification Assay test results were reported for stability samples. | Morton Grove Pharmaceuticals, Inc. / 39,187 bottles | Class III | Terminated |
