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-0421-2016 | 10-19-2015 | Calcium Chloride Dihydrate Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0478-2016 | 10-19-2015 | Super B Complex w/Cyano Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 4 containers | Class II | Terminated |
| D-0423-2016 | 10-19-2015 | Calcium Gluconate 10% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0415-2016 | 10-19-2015 | Methylcobalamin Injection 10 mg/mL, 20 mg/mL, 30 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 34 containers | Class II | Terminated |
| D-0400-2016 | 10-19-2015 | Butor/Nal/Hydro Nasal Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0413-2016 | 10-19-2015 | Medroxyprogesterone 150/LID 5 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 17 containers | Class II | Terminated |
| D-0457-2016 | 10-19-2015 | Test Cyp/Test Prop 1:1 Injection 100mg/mL, 120mg/mL, 150mg/mL, 160mg/mL, 170mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 75 containers | Class II | Terminated |
| D-0432-2016 | 10-19-2015 | Jessners Dermal Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0472-2016 | 10-19-2015 | 17-Hydroxyprogesterone 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 41 containers | Class II | Terminated |
| D-0418-2016 | 10-19-2015 | Ascorbic Acid 500 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 6 containers | Class II | Terminated |
| D-0417-2016 | 10-19-2015 | Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 3 containers | Class II | Terminated |
| D-0482-2016 | 10-19-2015 | Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0450-2016 | 10-19-2015 | Sermorelin Injection 10mg/10mL,10mg/mL, 20mg/10mL, 9mg/9mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 45 containers | Class II | Terminated |
| D-0410-2016 | 10-19-2015 | Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0484-2016 | 10-19-2015 | Salicylic Acid Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0452-2016 | 10-19-2015 | Sodium Bicarbonate 8.4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 4 containers | Class II | Terminated |
| D-0447-2016 | 10-19-2015 | PZI 40 Insulin (Human) Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 9 containers | Class II | Terminated |
| D-0479-2016 | 10-19-2015 | Tacrolimus 0.03% Opth Oint, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 3 containers | Class II | Terminated |
| D-0449-2016 | 10-19-2015 | Sal-Acid 60% Plaster Paste, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0476-2016 | 10-19-2015 | Lipodissolve 100/50mg Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0466-2016 | 10-19-2015 | Verapamil 120mg/12mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0411-2016 | 10-19-2015 | M-Cobalamin (B12) Injection 200 mcg, 2000mcg, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 3 containers | Class II | Terminated |
| D-0442-2016 | 10-19-2015 | Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0456-2016 | 10-19-2015 | Tacrolimus 0.02% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0396-2016 | 10-19-2015 | AMP50/B121MG Complex Mix/ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 4 containers | Class II | Terminated |
| D-0436-2016 | 10-19-2015 | Magnesium Sulfate 50% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 4 containers | Class II | Terminated |
| D-0433-2016 | 10-19-2015 | Ketorolac 40mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0477-2016 | 10-19-2015 | Super B Complex 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0430-2016 | 10-19-2015 | Heparin Sodium 30,000U/30ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0470-2016 | 10-19-2015 | Wilson's Nasal Irrigation Solution, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0464-2016 | 10-19-2015 | Tri-Mix ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 68 containers | Class II | Terminated |
| D-0441-2016 | 10-19-2015 | Phenylephrine 500mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0420-2016 | 10-19-2015 | Benadryl 50mg/2mL Pres-Free Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0419-2016 | 10-19-2015 | Cantharitus Multi-Mix Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0426-2016 | 10-19-2015 | Dexpanthanol B5 250mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 4 containers | Class II | Terminated |
| D-0414-2016 | 10-19-2015 | Methylcobalamin Injection 1000 mcg/mL, 10000 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 46 containers | Class II | Terminated |
| D-0438-2016 | 10-19-2015 | N.A.C. 20% SVN Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0435-2016 | 10-19-2015 | Magnesium Chloride Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0427-2016 | 10-19-2015 | Dextrose 50% Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0446-2016 | 10-19-2015 | Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 3 containers | Class II | Terminated |
| D-0416-2016 | 10-19-2015 | Mupiro/Doxycyc Sinus Rinse, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 conatiners | Class II | Terminated |
| D-0459-2016 | 10-19-2015 | Testosterone Injection 100mg/mL, 200mg/mL, 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 39 containers | Class II | Terminated |
| D-0480-2016 | 10-19-2015 | Triamcin 40mg/mL Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0408-2016 | 10-19-2015 | Glutathione 300 mg/1.5 mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0462-2016 | 10-19-2015 | Testosterone CYP Inj 200 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0443-2016 | 10-19-2015 | Potassium Chloride 40 mEq/mL Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0434-2016 | 10-19-2015 | Lidocaine Injection 1% , 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 4 containers | Class II | Terminated |
| D-0402-2016 | 10-19-2015 | Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 9 containers | Class II | Terminated |
| D-0437-2016 | 10-19-2015 | Marcaine 0.24%/Ethanol 4% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 5 containers | Class II | Terminated |
| D-0405-2016 | 10-19-2015 | Furosemide 20 mg/mL svn Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0471-2016 | 10-19-2015 | Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0429-2016 | 10-19-2015 | Heparin 1000 Unit/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0473-2016 | 10-19-2015 | Sodium Chloride 0.9% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0453-2016 | 10-19-2015 | Squaric Acid 4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0467-2016 | 10-19-2015 | Vitamin B12 (Cyan) Inj 100mcg/mL, 1000mcg/mL, Rx Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 8 containers | Class II | Terminated |
| D-0428-2016 | 10-19-2015 | HCG 10,000U/10mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona | Lack of Assurance of Sterility | Western Drug / 8 container | Class II | Terminated |
| D-0422-2016 | 10-19-2015 | Calcium EDTA 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0409-2016 | 10-19-2015 | Hydroxocobalamin 1mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 3 containers | Class II | Terminated |
| D-0425-2016 | 10-19-2015 | Cyancobalamin 2000mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 5 containers | Class II | Terminated |
| D-0399-2016 | 10-19-2015 | Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0412-2016 | 10-19-2015 | M-Cobalamin 2/Folate 5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0444-2016 | 10-19-2015 | Procaine HCl Injection 1%, 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0406-2016 | 10-19-2015 | Gent 80 mg/Liter Nasal, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0454-2016 | 10-19-2015 | Super B Comp w/Cyano 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 15 containers | Class II | Terminated |
| D-0469-2016 | 10-19-2015 | VitB12/VitC/VitB3/VitB9 Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 4 containers | Class II | Terminated |
| D-0461-2016 | 10-19-2015 | Toradol 60mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0407-2016 | 10-19-2015 | Glutathione 200 mg/mL SVN Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0394-2016 | 10-19-2015 | Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 16 containers | Class II | Terminated |
| D-0440-2016 | 10-19-2015 | Omnitrope 17.4U/10mL Inj-Kit, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 18 containers | Class II | Terminated |
| D-0460-2016 | 10-19-2015 | Tev-Tropin (Somatropin) Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 6 containers | Class II | Terminated |
| D-0397-2016 | 10-19-2015 | B-12 1000/B6 1000 mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0395-2016 | 10-19-2015 | Ace-Promazine 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0431-2016 | 10-19-2015 | Hydrochloric Acid 2mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 2 containers | Class II | Terminated |
| D-0398-2016 | 10-19-2015 | Bladder Mixture Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 4 containers | Class II | Terminated |
| D-0448-2016 | 10-19-2015 | Quad Mix Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 15 containers | Class II | Terminated |
| D-0463-2016 | 10-19-2015 | Tri-Amino OAC 1:1:1 300mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 36 containers | Class II | Terminated |
| D-0455-2016 | 10-19-2015 | T.C.A 30% Acid Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0445-2016 | 10-19-2015 | Progesterone Cyp Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 1 container | Class II | Terminated |
| D-0465-2016 | 10-19-2015 | Tri-Test 1:1:1 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Western Drug / 3 containers | Class II | Terminated |
| D-0367-2016 | 10-16-2015 | Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 289 vials | Class II | Terminated |
| D-0373-2016 | 10-16-2015 | Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 280 vials | Class II | Terminated |
| D-0365-2016 | 10-16-2015 | Hydroxocobalamin Injection (Buffered) 1mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 106 vials | Class II | Terminated |
| D-0350-2016 | 10-16-2015 | Magnesium Sulfate 50% Injectable, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 320 vials | Class II | Terminated |
| D-0345-2016 | 10-16-2015 | Procaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 881 vials | Class II | Terminated |
| D-0339-2016 | 10-16-2015 | L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 16 vials | Class II | Terminated |
| D-0347-2016 | 10-16-2015 | Vitamin D3 Injectable, 10,000 U/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 27 vials | Class II | Terminated |
| D-0351-2016 | 10-16-2015 | Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 20 vials | Class II | Terminated |
| D-0338-2016 | 10-16-2015 | L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 29 vials | Class II | Terminated |
| D-0349-2016 | 10-16-2015 | Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 123 vials | Class II | Terminated |
| D-0383-2016 | 10-16-2015 | MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 49 vials | Class II | Terminated |
| D-0379-2016 | 10-16-2015 | Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 34 vials | Class II | Terminated |
| D-0366-2016 | 10-16-2015 | B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 98 vials | Class II | Terminated |
| D-0356-2016 | 10-16-2015 | Chromium Injectable, 200mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 30 vials | Class II | Terminated |
| D-0363-2016 | 10-16-2015 | Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 286 vials | Class II | Terminated |
| D-0340-2016 | 10-16-2015 | EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 2279 vials | Class II | Terminated |
| D-0384-2016 | 10-16-2015 | Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 315 vials | Class II | Terminated |
| D-0378-2016 | 10-16-2015 | Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 72 vials | Class II | Terminated |
| D-0375-2016 | 10-16-2015 | Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 235 vials | Class II | Terminated |
| D-0364-2016 | 10-16-2015 | Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 287 vials | Class II | Terminated |
| D-0359-2016 | 10-16-2015 | DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435 | Lack of Assurance of Sterility | Downing Labs, LLC / 475 vials | Class II | Terminated |
