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-0333-2017 | 09-21-2016 | Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectable, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / Unknown | Class II | Terminated |
| D-0378-2017 | 09-21-2016 | Mitomycin Solution Injectable, Sterile 0.04%, 400 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 41 syringes | Class II | Terminated |
| D-0399-2017 | 09-21-2016 | Testosterone Cypionate / Zinc Sulf in Grapeseed Oil Injectable, 200 mg/200 mcg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 266 vials | Class II | Terminated |
| D-0357-2017 | 09-21-2016 | Forskolin/PAPAV/PHEN/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL, 5 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 22 vials | Class II | Terminated |
| D-0388-2017 | 09-21-2016 | Sermorelin Acetate 9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 629 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0335-2017 | 09-21-2016 | ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 325 vials | Class II | Terminated |
| D-0361-2017 | 09-21-2016 | Glutathione 200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 148 vials | Class II | Terminated |
| D-0376-2017 | 09-21-2016 | MIC+B12(M)+Carnitine 12.5 mg/50 mg/100 mg/1 mg/50 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 159 | Class II | Terminated |
| D-0337-2017 | 09-21-2016 | Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 24 vials, b) 91 vials | Class II | Terminated |
| D-0394-2017 | 09-21-2016 | Sermorelin Acetate/GHRP (2) 3 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 3 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0380-2017 | 09-21-2016 | Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 2,336 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0383-2017 | 09-21-2016 | QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 1,165 vials b) 2,217 vials | Class II | Terminated |
| D-0395-2017 | 09-21-2016 | Sermorelin Acetate/GHRP (2) 9 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 2,264 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0347-2017 | 09-21-2016 | Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 1753 kits (number of vials per kit vary) | Class II | Terminated |
| D-0391-2017 | 09-21-2016 | Sermorelin Acetate/GHRP (2) 9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 158 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0329-2017 | 09-21-2016 | Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 1,250 vials | Class II | Terminated |
| D-0418-2017 | 09-21-2016 | Trimix Injectable 30 mg/3 mg/60 mcg/mL, a) 2 mL, b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 2 vials,, b) 9 vials and 6 vials | Class II | Terminated |
| D-0381-2017 | 09-21-2016 | NADH/Carnitine/Taurine/B12(M) Injectable, 100 mg/150 mg/150 mg/10 mg, Lyophilized Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 219 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0366-2017 | 09-21-2016 | Methylcobalamin 5,000 mcg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 265 vials | Class II | Terminated |
| D-0346-2017 | 09-21-2016 | Chorionic Gonadotropin (New York State), 11,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 18 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0405-2017 | 09-21-2016 | Titan Up (INOS/CHOL/LEU/CAR/CHRO/LID) Injectable 25 mg/25 mg/1.5 mg/25 mg/0.025 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 433 vials | Class II | Terminated |
| D-0349-2017 | 09-21-2016 | Chorionic Gonadotropin, Lyophilized, 6,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 2,339 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0410-2017 | 09-21-2016 | Trimix with Atropine Injectable 30 mg/3 mg/300 mcg/0.2 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 3 vials | Class II | Terminated |
| D-0336-2017 | 09-21-2016 | Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 10 kits | Class II | Terminated |
| D-0419-2017 | 09-21-2016 | Tri-Test 200 (CEP 100-75-25) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 550 vials | Class II | Terminated |
| D-0385-2017 | 09-21-2016 | QUAD4 (PAP/PHEN/ALPROS/ATRO) 30 mg/3 mg/60 mcg/0.2 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 114 vials and b) 1,017 vials | Class II | Terminated |
| D-0375-2017 | 09-21-2016 | MIC/Chromium/B12(M) Injectable, 25 mg/50 mg/50 mg/25 mcg/1 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 648 vials | Class II | Terminated |
| D-0398-2017 | 09-21-2016 | Sodium Bicarbonate, 8.4% Injectable, 30 mL MultiDose vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 67 vials | Class II | Terminated |
| D-0392-2017 | 09-21-2016 | Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 176 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0334-2017 | 09-21-2016 | ULTRA-TEST in Grapeseed Oil (CYP 90%/PROP 10%) Injectable, 200 mg/mL, 8 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 714 vials | Class II | Terminated |
| D-0409-2017 | 09-21-2016 | Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 mg/mL, a) 2 mL b) 5 mL and 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 6 vials, b) 19 vials and c) 41 vials | Class II | Terminated |
| D-0414-2017 | 09-21-2016 | Trimix Injectable 17.65 mg/0.59 mg/5.9 mcg/mL a) 2 mL, b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 2 vials b) 3 vials and c) 7 vials | Class II | Terminated |
| D-0340-2017 | 09-21-2016 | Arginine HCl 100 mg/mL Injectable,10 mL, Compounded by Wells Pharmacy Network, LLC, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 351 vials | Class II | Terminated |
| D-0403-2017 | 09-21-2016 | Testosterone Cypionate/Anastrozole Injectable, 200 mg/1 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 203 vials | Class II | Terminated |
| D-0382-2017 | 09-21-2016 | Nandrolone Decanote (H), 200 mg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 526 vials | Class II | Terminated |
| D-0348-2017 | 09-21-2016 | Chorionic Gonadotropin, Lyophilized, 5,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 5277 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0367-2017 | 09-21-2016 | Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 7 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0384-2017 | 09-21-2016 | QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and b) 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 191 vials and b) 794 vials | Class II | Terminated |
| D-0343-2017 | 09-21-2016 | Bimix 30 mg/1 mg/mL Injectable, a) 5 mL and b) 10 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 80 vials, b) 23 vials | Class II | Terminated |
| D-0339-2017 | 09-21-2016 | Alprostadil 40 mcg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 37 vials | Class II | Terminated |
| D-0397-2017 | 09-21-2016 | Sermorelin Acetate/GHRP (6) 6 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 1,232 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0356-2017 | 09-21-2016 | Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 203 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0393-2017 | 09-21-2016 | Sermorelin Acetate/GHRP (2)/Theanine 15 mg/5.4 mg/75 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 1,255 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0379-2017 | 09-21-2016 | Mitomycin 20 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 315 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0411-2017 | 09-21-2016 | Trimix with Atropine Injectable 30 mg/3 mg/60 mcg/0.2 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 1 vial | Class II | Terminated |
| D-0374-2017 | 09-21-2016 | MIC/B-COMPLEX 15 mg/50 mg/100 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 984 vials | Class II | Terminated |
| D-0413-2017 | 09-21-2016 | Trimix Injectable 30 mg/2 mg/20 mcg, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 56 vials and b) 48 vials | Class II | Terminated |
| D-0354-2017 | 09-21-2016 | Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 16 vials | Class II | Terminated |
| D-0342-2017 | 09-21-2016 | B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 180 vials | Class II | Terminated |
| D-0372-2017 | 09-21-2016 | MIC/B-COMP+CARN+LIDO, 15 mg/30 mg/30 mg/85 mg/20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 1716 vials | Class II | Terminated |
| D-0370-2017 | 09-21-2016 | MIC/B-COMP/(M)/CHROM/CARN, 20 mg/40 mg/50 mg/25 mcg/25 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 933 vials | Class II | Terminated |
| D-0363-2017 | 09-21-2016 | Inositol/Choline/B-Complex+Leucine+CARN+CHROM+LIDO (LipoLean), Injectable, 30 mL vial, Compounded by Wells Pharmacy. Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 433 vials | Class II | Terminated |
| D-0353-2017 | 09-21-2016 | Dexamethasone Sodium Phosphate 200 mg/mL, Injectable, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 15 vials | Class II | Terminated |
| D-0402-2017 | 09-21-2016 | Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 798 vials and b) 3,191 vials | Class II | Terminated |
| D-0328-2017 | 09-21-2016 | ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 157 vials | Class II | Terminated |
| D-0352-2017 | 09-21-2016 | Chorionic Gonadotropin+B12(C), Lyophilized, 10,000 unit + 40 mcg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 724 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0407-2017 | 09-21-2016 | Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 257 vials and b) 460 vials | Class II | Terminated |
| D-0416-2017 | 09-21-2016 | Trimix Injectable 30 mg/1 mg/25 mcg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 7 vials | Class II | Terminated |
| D-0406-2017 | 09-21-2016 | TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 18 vials | Class II | Terminated |
| D-0422-2017 | 09-21-2016 | Testosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 4 vials | Class II | Terminated |
| D-0360-2017 | 09-21-2016 | Glutamine/ORNI/ARGIN/LYSINE/LIDO Injectable, 75 mg/75 mg/150 mg/150 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 199 vials | Class II | Terminated |
| D-0338-2017 | 09-21-2016 | Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 21 vials | Class II | Terminated |
| D-0400-2017 | 09-21-2016 | Testosterone Cypionate in Grapeseed Oil Injectable, 100 mg/mL, a) 1mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a ) 303 vials and b) 413 vials | Class II | Terminated |
| D-0369-2017 | 09-21-2016 | MIC/B12/CAR/CHR/LYS/DMG 25 mg/50 mg/50 mg/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL Injectable, 30 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 106 vials | Class II | Terminated |
| D-0404-2017 | 09-21-2016 | Testosterone Propionate Injectable, 100 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 469 vials | Class II | Terminated |
| D-0423-2017 | 09-21-2016 | Testosterone Cypionate in Sesame Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 3 vials | Class II | Terminated |
| D-0358-2017 | 09-21-2016 | Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 147 vials | Class II | Terminated |
| D-0362-2017 | 09-21-2016 | Indocyanine Green (P.F.), 15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 131 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0420-2017 | 09-21-2016 | Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 237 vials | Class II | Terminated |
| D-0390-2017 | 09-21-2016 | Sermorelin Acetate/GHRP (2) & (6) 9 mg/9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 1,319 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0396-2017 | 09-21-2016 | Sermorelin Acetate/GHRP (6) 3 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 106 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0345-2017 | 09-21-2016 | Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells Pharmacy, Ocala , FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 46 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0417-2017 | 09-21-2016 | Trimix Injectable 30 mg/3 mg/100 mcg/mL, a) 5 mL and 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / a) 1 vial and b) 12 vials | Class II | Terminated |
| D-0387-2017 | 09-21-2016 | Sermorelin Acetate 28 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 330 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0359-2017 | 09-21-2016 | Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 137 vials | Class II | Terminated |
| D-0386-2017 | 09-21-2016 | Sermorelin Acetate 15 mg Injectable Kit., Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 568 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0364-2017 | 09-21-2016 | Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 189 vials | Class II | Terminated |
| D-0331-2017 | 09-21-2016 | Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 1,968 vials | Class II | Terminated |
| D-0389-2017 | 09-21-2016 | Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 3,089 kits (number of vials per kit vary by prescription) | Class II | Terminated |
| D-0344-2017 | 09-21-2016 | Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells Pharmacy, Ocala, FL | Lack of Assurance of Sterility | Wells Pharmacy Network LLC / 44 vials | Class II | Terminated |
| D-0014-2017 | 09-20-2016 | Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0012-2017 | 09-20-2016 | Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0017-2017 | 09-20-2016 | Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0010-2017 | 09-20-2016 | Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0011-2017 | 09-20-2016 | Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0016-2017 | 09-20-2016 | Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0018-2017 | 09-20-2016 | Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0013-2017 | 09-20-2016 | Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0015-2017 | 09-20-2016 | Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35 | Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters | Leiter's Compounding / 76,315 total units, all products | Class II | Terminated |
| D-0128-2017 | 09-19-2016 | Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 358 pellets | Class II | Terminated |
| D-0130-2017 | 09-19-2016 | Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 301 pellets | Class III | Terminated |
| D-0126-2017 | 09-19-2016 | Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 690 pellets | Class II | Terminated |
| D-0129-2017 | 09-19-2016 | Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 322 pellets | Class III | Terminated |
| D-0131-2017 | 09-19-2016 | Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 318 pellets | Class II | Terminated |
| D-0127-2017 | 09-19-2016 | Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 1 pellet | Class III | Terminated |
| D-0132-2017 | 09-19-2016 | Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network | Superpotent and Subpotent drugs | Wells Pharmacy Network, LLC / 353 pellets | Class III | Terminated |
| D-0097-2017 | 09-16-2016 | Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50. Package NDCs: 0409-1559-18; 0409-1559-10; 0409-1559-19; 0409-1559-30; 0409-1560-18; 0409-1560-10; 0409-1560-19; 0409-1560-29; 0409-1582-18; 0409-1582-10; 0409-1582-19; 0409-1582-29; 0409-1587-50; 0409-1610-50; 0409-1746-70; 0409-1746-10; 0409-1746-71; 0409-1746-30; 0409-1749-70; 0409-1749-10; 0409-1749-71; 0409-1749-29; 0409-1752-50; 0409-1755-50; 0409-2510-01; 0409-2510-25; 0409-7535-01; 0409-7535-25; 0409-1250-01; 0409-1250-25; 0409-5010-01; 0409-5010-25; 0409-1530-01; 0409-1530-25; 0409-0525-01; 0409-0525-25; 0409-7510-01; 0409-7510-25; 0409-2253-01; 0409-2253-25 | Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency. | Hospira Inc., A Pfizer Company / 4768 vials | Class II | Terminated |
| D-0096-2017 | 09-16-2016 | Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50. Package NDCs: 0409-1559-18; 0409-1559-10; 0409-1559-19; 0409-1559-30; 0409-1560-18; 0409-1560-10; 0409-1560-19; 0409-1560-29; 0409-1582-18; 0409-1582-10; 0409-1582-19; 0409-1582-29; 0409-1587-50; 0409-1610-50; 0409-1746-70; 0409-1746-10; 0409-1746-71; 0409-1746-30; 0409-1749-70; 0409-1749-10; 0409-1749-71; 0409-1749-29; 0409-1752-50; 0409-1755-50; 0409-2510-01; 0409-2510-25; 0409-7535-01; 0409-7535-25; 0409-1250-01; 0409-1250-25; 0409-5010-01; 0409-5010-25; 0409-1530-01; 0409-1530-25; 0409-0525-01; 0409-0525-25; 0409-7510-01; 0409-7510-25; 0409-2253-01; 0409-2253-25 | Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency. | Hospira Inc., A Pfizer Company / 15 vials | Class II | Terminated |
| D-1528-2016 | 09-15-2016 | PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91 Package NDCs: 0046-1101-81; 0046-1102-81; 0046-1102-91; 0046-1102-52; 0046-1104-81; 0046-1104-91; 0046-1100-81; 0046-1100-91; 0046-1100-52; 0046-1103-81 | Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17. | Pfizer Inc. / 1,316 bottles (1,316,000 tablets) | Class III | Terminated |
| D-1527-2016 | 09-15-2016 | Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10 | Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry). | Mckesson Packaging Services / 3,492 unit cartons of 10 x 10 blister cards | Class III | Terminated |
