Drug recall: Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300…
Class II FDA enforcement event 75763. Recall start date: . Status in the FDA record: Ongoing.
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
Tri-Coast Pharmacy started this drug recall on 17 Nov 2016. The firm address in the FDA record is in Juno Beach, FL. FDA put the recall in Class II. FDA event 75763 has 80 product records. The first FDA enforcement report date is 11 Jan 2017. The record gives the status Ongoing.
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
Tri-Coast Pharmacy, Juno Beach, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
80 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0246-2017 | Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 mg/Thiamine HCL 50 mg/Riboflavin-5-Phosphate Sod 5 mg/Niacinamide 20 mg/Pyridoxine HCL 2 mg/Folic Acid 2 mg/Ascorbic Acid 50 mg/Chromium Picolinate 200 mcg/Glutamine (L) 30… | 59 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0247-2017 | Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + L-Taurine 0.7 mg/ml. Compounded by Tri-Coast Pharmacy. | 105 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0248-2017 | Ascorbic Acid 500 mg/mL (50 ML). Compounded by Tri-Coast Pharmacy. | 201 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0249-2017 | BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocaine HCL 10 mg/mL). Compounded by Tri-Coast Pharmacy. | 265 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0250-2017 | B-Complex (30 ML), (Thiamine HCL 100 mg/Riboflavin-5-Phosphate 2 mg/Pyridoxine HCL 2 mg/Niacinamide 100 mg/Methylcobalamin 300 mcg/ml). Compounded by Tri-Coast Pharmacy. | 67 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0251-2017 | BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy. | 28 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0252-2017 | BiMix Phentolamine/Papaverine 1 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy | 5 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0253-2017 | BiMix Phentolamine/Papaverine 2 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy | 2 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0254-2017 | Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy | 12 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0255-2017 | Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan (L) 10 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy. | 10 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0256-2017 | Dexpanthenol 250 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy | 5 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0257-2017 | GAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 mg/mL (30 mL). Tri-Coast Pharmacy. | 114 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0258-2017 | Glucosamine 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy | 30 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0259-2017 | Glutamine 25 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy | 12 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0260-2017 | Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy | 367 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0261-2017 | HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy. | 4,884 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0262-2017 | HCG/Hydroxycobalamin 5,000 IU/5 mg Vial. Compounded by Tri-Coast Pharmacy | 1,304 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0263-2017 | HCG 11,000 IU Vial. Compounded by Tri-Coast Pharmacy | 5,229 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0264-2017 | Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL). 30 ML. Compounded by Tri-Coast Pharmacy. | 161 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0265-2017 | IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL), (30 ML). Compounded by Tri-Coast Pharmacy | 132 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0266-2017 | L-Arginine HCL 100 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy | 41 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0267-2017 | L-Carnitine 250 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy | 14 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0268-2017 | L-Tyrosine 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy | 50 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0269-2017 | Lipo-C (Methionine 25 mg/Inositol 50 mg/Choline Chloride 50 mg/Carnitine (L) 100 mg/Methylcobalamin 1 mg/Thiamine HCL 50 mg/Rivoflavin-5-Phosphate Sod 5 mg/Niacinamide 50 mg/Dexpanthenol 5 mg/Pyridoxine HCL 1.25 mg/Lidocaine HCL 10 mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy | 69 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0270-2017 | Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy | 987 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0271-2017 | Lipotropic with MIC (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/L-Carnitine 170 mg + Methylcopalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-Phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 20mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy | 236 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0272-2017 | Methylcobalamin 1,000 mcg/mL, 10 mL and 30 mL. Compounded by Tri-Coast Pharmacy | 1,458 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0273-2017 | Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL, 1 ML). Compounded by Tri-Coast Pharmacy | 99 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0274-2017 | Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg/10-mL), (10 ML). Compounded by Tri-Coast Pharmacy | 66 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0275-2017 | Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg + Folic Acid 1 mg + Vitamin E Succinate 10 IU + Vitamin A Acetate 100 IU/10-mL), (10… | 21 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0276-2017 | MIC Ultra Cocktail (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 700mcg/Chromium Picolinate 20 mcg/Pyridoxine HCL 2mg/ml), (10 ML). Compounded by Tri-Coast Pharmacy | 278 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0277-2017 | Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + Sodium Molybdate 250 mcg/ml + Strontium Chloride 3 mg/ml + Lithium Citrate 5 mg/ml + Chromium Picolinate 100 mcg/ml + Boron Citrate 1798 mg/ml + Sodium Selenite 200 mcg.ml + Cupric Sulfate 1 mg/ml, (30 ML). Compounded by… | 36 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0278-2017 | Nandrolone Decanoate 200 mg/ml, (5 ML). Compounded by Tri-Coast Pharmacy | 701 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0279-2017 | Pyridoxine HCL 100 mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy | 3 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0280-2017 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy | 5 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0281-2017 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy | 2 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0282-2017 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy | 10 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0283-2017 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy | 10 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0284-2017 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy | 5 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0285-2017 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy | 5 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0286-2017 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 18mcg/1mg/1.8mg/0.02mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy | 17 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0287-2017 | Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy | 260 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0288-2017 | Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy | 54 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0289-2017 | Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy | 91 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0290-2017 | Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by Tri-Coast Pharmacy | 7 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0291-2017 | Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg). Compounded by Tri-Coast Pharmacy | 188 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0292-2017 | Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded by Tri-Coast Pharmacy | 441 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0293-2017 | Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg). Compounded by Tri-Coast Pharmacy | 2116 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0294-2017 | Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). Compounded by Tri-Coast Pharmacy | 920 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0295-2017 | Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 1 mg/Pyridoxine HCL 2.2mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy | 127 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0296-2017 | Taurine 50 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy | 90 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0297-2017 | Testosterone Cypionate in Sesame, 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy | 166 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0298-2017 | Testosterone Cypionate in Sesame, 150 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy | 400 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0299-2017 | Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy | 2,818 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0300-2017 | Testosterone Cypionate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy | 7,168 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0301-2017 | Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy | 1,544 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0302-2017 | Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy | 1,244 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0303-2017 | Testosterone Cypionate/Propionate, 200 mg/50 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy | 152 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0304-2017 | Testosterone Cypionate/Enanthate/Propionate, 160 mg/20 mg/20 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy | 882 vials | Class II | Ongoing | 11 Jan 2017 |
| D-0305-2017 | Testosterone Enanthate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy | 1,567 vials | Class II | Ongoing | 11 Jan 2017 |
The table shows 60 of 80 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
- 80
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-0246-2017The 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.
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Cite this page
Recall Register. FDA enforcement event 75763. https://recallregister.com/fda/ii/75763/. 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 75763?
- The event has 80 product records. The first record gives this quantity:
59 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.