CLASS II ONGOING Drug recall · Reported 11 Jan 2017 · FDA Enforcement Report

Sermorelin GT (Sermorelin Acetate 15 mg/Ghrp recalled

Tri-Coast Pharmacy is recalling Sermorelin GT (Sermorelin Acetate 15 mg/Ghrp-2 5.4 mg/Theanine (L) 75 mg), distributed nationwide in the US. The recall was initiated on 17 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRecall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06152016B (12/12/2016), 07252016C (01/21/2017), 08262016C (02/22/2017), 10192016A (02/28/2017), 10242016B (02/28/2017).

Quantity recalled920 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0294-2017
FDA event ID: 75763
Recalling firm: Tri-Coast Pharmacy, Juno Beach, FL
Classification: Class II
Status: Ongoing
Recall initiated: 17 Nov 2016
FDA classified: 4 Jan 2017
Reported: 11 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Drug class: Compounded Drugs

Timeline

17 Nov 2016	Recall initiated by company
4 Jan 2017	Classified by FDA	+48 days
11 Jan 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). Compounded by Tri-Coast Pharmacy

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06152016B (12/12/2016), 07252016C (01/21/2017), 08262016C (02/22/2017), 10192016A (02/28/2017), 10242016B (02/28/2017).

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

79 other products · FDA event 75763

This product is part of a recall event; the main page for the event is TriMix, Alprostadil/Phentolamine/Papaverine recalled.

Reported	Class	Recall	Company	Reason	Where
11 Jan 2017	CLASS II	TriMix, Alprostadil/Phentolamine/Papaverine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Propionate 100 mg/mL. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Ultra Amino Blend (Arginine HCL 105 mg + Lysine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Ultra Amino Energy Cocktail (Methionine recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	BiMix Phentolamine/Papaverine 1 mg/30 mg/mL. Compounded recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Glutathione 200 mg/mL. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Glucosamine 200 mg/mL. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	BCAA (Isoleucine (L) 15 mg + Leucine recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Suspension 100 mg/mL. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate/Propionate recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Taurine 50 mg/mL. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Ultra Cocktail #2 (Methionine recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Ultra Slim Shot (Methionine recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	BiMix Phentolamine/Papaverine 2 mg/30 mg/mL. Compounded recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Forte Plus 18 mg recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	L-Carnitine 250 mg/mL. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	TriMix, Alprostadil/Phentolamine/Papaverine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Pyridoxine HCL 100 mg/ml. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Vitamin D3/mL, in olive oil recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Forte Plus 27 mg recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	TriMix, Alprostadil/Phentolamine/Papaverine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	TriMix, Alprostadil/Phentolamine/Papaverine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	TriMix, Alprostadil/Phentolamine/Papaverine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	TriMix, Alprostadil/Phentolamine/Papaverine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	HCG/Hydroxycobalamin 5,000 IU/5 mg Vial recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	TriMix, Alprostadil/Phentolamine/Papaverine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	TriMix, Alprostadil/Phentolamine/Papaverine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate/Enanthate/Propionate recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Lipotropic with MIC (Methionine recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate in Sesame recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Lipo-C (Methionine 25 mg/Inositol 50 mg/Choline Chloride recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate in Sesame recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate in Sesame Oil recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	GAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	TriMix, Alprostadil/Phentolamine/Papaverine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/Ghrp-6 mg) recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Nandrolone Decanoate 200 mg/ml. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Calcium Gluconate 10% Injection recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	B-Complex, (Thiamine HCL 100 mg/Riboflavin-5-Phosphate recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	TriMix, Alprostadil/Phentolamine/Papaverine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL. Compounded recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/Ghrp-6 3 mg) recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate in Sesame Oil recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL. recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	L-Tyrosine 10 mg/mL. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Glutamine 25 mg/mL. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Ascorbic Acid 500 mg/mL. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	MIC Ultra Cocktail (Methionine recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Methylcobalamin 1,000 mcg/mL and Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	TriMix, Alprostadil/Phentolamine/Papaverine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Enanthate in Sesame Oil recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Testosterone Cypionate in Grapeseed, 200 mg/mL recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	TriMix, Alprostadil/Phentolamine/Papaverine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Dexpanthenol 250 mg/mL. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	L-Arginine HCL 100 mg/mL. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	HCG 11,000 IU Vial recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	HCG 5,000 IU Vial recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Amino Acid Recover Eaze, Phenylaline (L) 8 mg/ml + Tyrosine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017	CLASS II	Amino Energy Cocktail, (Methionine recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide

More recalls from Tri-Coast Pharmacy

All 80

Reported	Class	Recall	Company	Reason	Where
11 Jan 2017Drug	CLASS II	Amino Energy Cocktail, (Methionine recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Amino Acid Recover Eaze, Phenylaline (L) 8 mg/ml + Tyrosine recalled	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	HCG 5,000 IU Vial recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	HCG 11,000 IU Vial recalled by Tri-Coast Pharmacy	Tri-Coast Pharmacy	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	L-Arginine HCL 100 mg/mL. Compounded by Tri-Coast Pharmacy recalled	Tri-Coast Pharmacy	Sterility	Nationwide