Drug recall: Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded…
Class II FDA enforcement event 75289. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Wells Pharmacy Network LLC started this drug recall on 21 Sep 2016. The firm address in the FDA record is in Ocala, FL. FDA put the recall in Class II. FDA event 75289 has 97 product records. The first FDA enforcement report date is 11 Jan 2017. The record gives the status Terminated, with the termination date 2 Jul 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide
Recalling firm
Wells Pharmacy Network LLC, Ocala, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
97 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0327-2017 | Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL | a) 694 vials b) 389 vials c) 695 vials d) 5193 vials | Class II | Terminated | 11 Jan 2017 |
| D-0328-2017 | ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 157 vials | Class II | Terminated | 11 Jan 2017 |
| D-0329-2017 | Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 1,250 vials | Class II | Terminated | 11 Jan 2017 |
| D-0330-2017 | QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL | a) 1,312 vials and b) 3,354 vials | Class II | Terminated | 11 Jan 2017 |
| D-0331-2017 | Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 1,968 vials | Class II | Terminated | 11 Jan 2017 |
| D-0332-2017 | MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounded by Wells Pharmacy, Ocala, FL | 308 vials | Class II | Terminated | 11 Jan 2017 |
| D-0333-2017 | Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectable, Compounded by Wells Pharmacy, Ocala, FL | Unknown | Class II | Terminated | 11 Jan 2017 |
| D-0334-2017 | ULTRA-TEST in Grapeseed Oil (CYP 90%/PROP 10%) Injectable, 200 mg/mL, 8 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 714 vials | Class II | Terminated | 11 Jan 2017 |
| D-0335-2017 | ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 325 vials | Class II | Terminated | 11 Jan 2017 |
| D-0336-2017 | Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | 10 kits | Class II | Terminated | 11 Jan 2017 |
| D-0337-2017 | Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL | a) 24 vials, b) 91 vials | Class II | Terminated | 11 Jan 2017 |
| D-0338-2017 | Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 21 vials | Class II | Terminated | 11 Jan 2017 |
| D-0339-2017 | Alprostadil 40 mcg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL | 37 vials | Class II | Terminated | 11 Jan 2017 |
| D-0340-2017 | Arginine HCl 100 mg/mL Injectable,10 mL, Compounded by Wells Pharmacy Network, LLC, Ocala, FL | 351 vials | Class II | Terminated | 11 Jan 2017 |
| D-0341-2017 | Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network, LLC, Ocala, FL | 30 vials | Class II | Terminated | 11 Jan 2017 |
| D-0342-2017 | B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL | 180 vials | Class II | Terminated | 11 Jan 2017 |
| D-0343-2017 | Bimix 30 mg/1 mg/mL Injectable, a) 5 mL and b) 10 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL | a) 80 vials, b) 23 vials | Class II | Terminated | 11 Jan 2017 |
| D-0344-2017 | Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells Pharmacy, Ocala, FL | 44 vials | Class II | Terminated | 11 Jan 2017 |
| D-0345-2017 | Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells Pharmacy, Ocala , FL | 46 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
| D-0346-2017 | Chorionic Gonadotropin (New York State), 11,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | 18 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
| D-0347-2017 | Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | 1753 kits (number of vials per kit vary) | Class II | Terminated | 11 Jan 2017 |
| D-0348-2017 | Chorionic Gonadotropin, Lyophilized, 5,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | 5277 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
| D-0349-2017 | Chorionic Gonadotropin, Lyophilized, 6,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | 2,339 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
| D-0350-2017 | Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | 1,638 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
| D-0351-2017 | Chorionic Gonadotropin Lyophilized, 20,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | 908 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
| D-0352-2017 | Chorionic Gonadotropin+B12(C), Lyophilized, 10,000 unit + 40 mcg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | 724 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
| D-0353-2017 | Dexamethasone Sodium Phosphate 200 mg/mL, Injectable, Compounded by Wells Pharmacy, Ocala, FL | 15 vials | Class II | Terminated | 11 Jan 2017 |
| D-0354-2017 | Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 16 vials | Class II | Terminated | 11 Jan 2017 |
| D-0355-2017 | DMSO (Dimethyl Sulfoxide) with Lidocaine 50%/0.5% mL Solution, 50 mL bottle, Compounded by Wells Pharmacy, Ocala, FL | 438 vials | Class II | Terminated | 11 Jan 2017 |
| D-0356-2017 | Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | 203 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
| D-0357-2017 | Forskolin/PAPAV/PHEN/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL, 5 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL | 22 vials | Class II | Terminated | 11 Jan 2017 |
| D-0358-2017 | 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 | 147 vials | Class II | Terminated | 11 Jan 2017 |
| D-0359-2017 | Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 137 vials | Class II | Terminated | 11 Jan 2017 |
| D-0360-2017 | 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 | 199 vials | Class II | Terminated | 11 Jan 2017 |
| D-0361-2017 | Glutathione 200 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 148 vials | Class II | Terminated | 11 Jan 2017 |
| D-0362-2017 | Indocyanine Green (P.F.), 15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL | 131 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
| D-0363-2017 | Inositol/Choline/B-Complex+Leucine+CARN+CHROM+LIDO (LipoLean), Injectable, 30 mL vial, Compounded by Wells Pharmacy. Ocala, FL | 433 vials | Class II | Terminated | 11 Jan 2017 |
| D-0364-2017 | Leucine/Isoleucine/Valine 10 mg/10 mg/5 mg/5 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 189 vials | Class II | Terminated | 11 Jan 2017 |
| D-0365-2017 | Methylcobalamin 1,000 mcg/mL Injectable, a) 10 mL vial and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | a) 499 vials b) 1214 vials | Class II | Terminated | 11 Jan 2017 |
| D-0366-2017 | Methylcobalamin 5,000 mcg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 265 vials | Class II | Terminated | 11 Jan 2017 |
| D-0367-2017 | Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit, Compounded by Wells Pharmacy, Ocala, FL | 7 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
| D-0368-2017 | MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 633 vials | Class II | Terminated | 11 Jan 2017 |
| D-0369-2017 | 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 | 106 vials | Class II | Terminated | 11 Jan 2017 |
| D-0370-2017 | 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 | 933 vials | Class II | Terminated | 11 Jan 2017 |
| D-0371-2017 | MIC/BCOMP+CAR+ARG+CHR+LID 12.5 mg/25 mg/25 mg/25 mg/12.5 mg/0.2 mg/20 mg/mL Injectable, a) 10 mL and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 511 vials | Class II | Terminated | 11 Jan 2017 |
| D-0372-2017 | 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 | 1716 vials | Class II | Terminated | 11 Jan 2017 |
| D-0373-2017 | MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 4 vials | Class II | Terminated | 11 Jan 2017 |
| D-0374-2017 | MIC/B-COMPLEX 15 mg/50 mg/100 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 984 vials | Class II | Terminated | 11 Jan 2017 |
| D-0375-2017 | 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 | 648 vials | Class II | Terminated | 11 Jan 2017 |
| D-0376-2017 | 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 | 159 | Class II | Terminated | 11 Jan 2017 |
| D-0377-2017 | Mitomycin Solution Injectable, Sterile 0.02%, 200 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL | 122 syringes | Class II | Terminated | 11 Jan 2017 |
| D-0378-2017 | Mitomycin Solution Injectable, Sterile 0.04%, 400 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL | 41 syringes | Class II | Terminated | 11 Jan 2017 |
| D-0379-2017 | Mitomycin 20 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL | 315 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
| D-0380-2017 | Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL | 2,336 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
| D-0381-2017 | NADH/Carnitine/Taurine/B12(M) Injectable, 100 mg/150 mg/150 mg/10 mg, Lyophilized Kit, Compounded by Wells Pharmacy, Ocala, FL | 219 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
| D-0382-2017 | Nandrolone Decanote (H), 200 mg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL | 526 vials | Class II | Terminated | 11 Jan 2017 |
| D-0383-2017 | 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 | a) 1,165 vials b) 2,217 vials | Class II | Terminated | 11 Jan 2017 |
| D-0384-2017 | 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 | a) 191 vials and b) 794 vials | Class II | Terminated | 11 Jan 2017 |
| D-0385-2017 | 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 | 114 vials and b) 1,017 vials | Class II | Terminated | 11 Jan 2017 |
| D-0386-2017 | Sermorelin Acetate 15 mg Injectable Kit., Compounded by Wells Pharmacy, Ocala, FL | 568 kits (number of vials per kit vary by prescription) | Class II | Terminated | 11 Jan 2017 |
The table shows 60 of 97 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2016
- 288
- Share of these events in Class II
- 46%
- Product records in this event
- 97Median of the firm: 97
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Sep 2016 | Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network | Drug | Class II | 7 |
Official channels
- FDA enforcement report D-0327-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 75289. https://recallregister.com/fda/ii/75289/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide
- What quantity of product is in FDA event 75289?
- The event has 97 product records. The first record gives this quantity:
a) 694 vials b) 389 vials c) 695 vials d) 5193 vials
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2016 have the same class?
- 46% of the 288 drug events that started in 2016 are in Class II.