Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared Between May 17, 2016 and November 17, 2016 Due to Concern Over Lack of Sterility Assurance
Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections which may be life-threatening. No portion of any lot of these medications has been found to be non-sterile, but the FDA is concerned that the conditions under which they were produced introduce a lack of sterility assurance for these products. To date, Tri-Coast Pharmacy has received no adverse event reports for these products.
The recalled drug products were used for a variety of indications. All recalled products have a Tri-Coast Pharmacy Inc. label that includes the name Tri-Coast Pharmacy Inc., our logo, the drug name, lot number and the expiration date. In the event a patient is unsure if their product is on the list of recalled drugs, we ask that they call the pharmacy to inquire. The phone number is 1 (561) 776-7510 or toll free at 1 (877) 823-3284.
Tri-Coast Pharmacy’s primary concern is to ensure patient safety. All patients and providers that received any sterile compounded products from Tri-Coast Pharmacy Inc. prepared between May 17, 2016 and November 17, 2016 and that remain with expiry, should take the following actions:
· Quarantine any unused product until further instruction are received
to facilitate the product being returned to Tri-Coast Pharmacy Inc.
· Discontinue the use of any products contained in the recall
· Please contact Tri-Coast Pharmacy Inc at 1 (561) 776-7510 or
our toll free number 1 (877) 823-3284, Monday through Friday, 10am to
6pm EST. or email at
pharmacist@tricoastrx.com to discuss the returning of any unused product associated with his recall.
Patients should contact their physician or healthcare provider if they have experienced any problems that may be associated with using these products. Providers who have dispensed any sterile products prepared between May 17, 2016 and November 17, 2016 to a patient should contact the patient(s) to whom the product was dispensed and make the patient(s) aware of this recall.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
· Complete and submit the report Online:
www.fda.gov/medwatch/report.htm
· Regular Mail or Fax: Download form
www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return
to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge and in cooperation with the U.S. Food and Drug Administration. Patient safety is the primary concern at Tri-Coast Pharmacy Inc. and we are taking this voluntary action out of an abundance of caution. Thank you.
The following is a list of products to be recalled,
7-Keto DHEA 40 mg/mL Suspension |
05312016C, 06292016B, 06282016E, 06082016F,
07142016B, 09272016F, 10182016B |
Adenosine-5 Monophosphate 100 mg/mL | 08052016B |
Amino Energy Cocktail
Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Niacinamide 20mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 50mg/Chromium Picolinate 200mcg/Glutamine (L) 30mg/Lidocaine HCL 10mg/mL |
06012016A, 07282016A |
Amino Acid Recover Eaze
Phenylalanine (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + Tryptophan (L) 1.5 mg/ml + Threonine 1 mg/ml + L-Taurine 0.7 mg/ml |
06072016C, 08162016E, 11012016H |
Ascorbic Acid 500 mg/mL |
07192016WW, 07152016G, 08292016A,
10262016B |
BCAA
Isoleucine (L) 15 mg + Leucine (L) 10 mg + Valine 40 mg + Lidocaine HCL 10 mg/ml |
07222016A, 08162016C, 08042016A, 10102016C,
11012016I, 10172016B |
B-Complex Compound
Thiamine HCL 100mg/Riboflavin-5-Phosphate 2mg/Pyridoxine HCL 2mg/Dexpanthenol 2mg/Niacinamide 100mg/Methylcobalamin 300mcg/ml |
07262016E, 10262016E |
BiMix
Phentolamine/Papaverine 0.06mg/1.8mg/mL |
06092016B, 07212016C, 09162016A, 11012016A |
BiMix
Phentolamine/Papaverine 1mg/30mg/mL |
07222016H |
BiMix
Phentolamine/Papaverine 2mg/30mg/mL |
09302016D |
Calcium Gluconate 10% Injection | 08172016A |
Calm Me
Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan (L) 10 mg/Lidocaine HCL 10mg/ml |
09212016A |
Dexpanthenol 250 mg/mL | 08162016B |
GAC
L-Glutamine/L-Arginine/L-Carnitine 25mg/100mg/200mg/mL |
06172016A, 08092016B, 09262016A, 10132016E |
Glucosamine 200 mg/mL | 10192016D |
Glutamine 25 mg/mL | 08032016A |
Glutathione 200 mg/mL |
06082016A, 07052016C, 08082016A, 09132016D,
10262016A |
HCG 5,000 IU Vial |
06222016D, 06062016C, 07192016C, 07062016A,
08182016B, 08112016A, 08012016A, 09282016A, 09122016D, 10182016C, 11042016B, 11012016F |
HCG/Hydroxycobalamin
5,000 IU/5mg Vial |
06232016A, 07192016B, 08262016A, 08092016C,
09192016C, 10102016F, 11042016C, 10252016A |
HCG 11,000 IU Vial |
06152016A, 07252016D, 07112016C, 08312016B,
08262016B, 08092016D, 08052016A, 09282016B, 09222016D,09072016A, 10252016J, 10182016D, 10102016H, 11042016A, 11012016E |
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 (Vitamin K1) 150 mcg/5-mL |
07062016D, 08312016A, 08232016C, 08222016C,
08102016E, 08102016D, 08012016E, 09262016C, 09132016C |
IV Cocktail #2
Ascorbic Acid 500 mg/Magnesium Chloride 8 mg/Methylcobalamin 50 mcg/ Dexpanthenol 2.5 mg/Folic Acid 50 mcg/B-Complex Inj 0.02ml/Vitamin E 0.1 unit/Vitamin A 1 unit/mL |
05252016D, 05202016A, 05182016C, 05092016C,
05022016C, 06132016D, 06072016A, 06062016A, 07282016E, 07252016G, 09122016A, 09192016B |
L-Arginine HCL 100 mg/mL | 07282016H, 09282016E |
L-Carnitine 250 mg/mL | 09132016F |
L-Tyrosine 10 mg/mL | 07292016A, 07182016E, 08222016A, 10192016A |
Lipo-C
Methionine 25mg/Inositol 50mg/Choline Chloride 50mg/Carnitine (L) 100 mg/ Methylcobalamin 1mg/ Thiamine HCL 50mg/Riboflavin- 5-Phosphate Sod 5mg/ Niacinamide 50mg/ Dexpanthenol 5mg/ Pyridoxine HCL 1.25mg/ Lidocaine HCL 10mg/mL |
07282016B, 08242016B |
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 10mg/ml |
09022016A, 07282016C |
Lipotropic with MIC
Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/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 20mg/ml |
06012016B, 07082016A, 10032016C, 08242016C |
Methylcobalamin 1,000 mcg/mL |
05132016KK, 05262016A, 06092016A,
07262016B, 07062016C, 08292016B, 10132016F, 10252016K, 07262016C, 09152016C |
Methylcobalamin/Folic Acid/Pyridoxine
1 mg/1 mg/50 mg/mL |
05232016A, 06282016B, 06212016A, 06142016A,
06072016E, 06022016B, 06022016A, 07262016H, 07192016A, 07122016A,07082016D, 07062016B, 08302016B, 08232016D, 08162016D, 08092016E, 08042016F, 09122016E, 09272016D, 09272016B, 09202016A, 09132016A, 09072016B, 10112016D, 10042016B, 11022016A, 11092016A, 11082016A |
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 |
06202016DD, 09132016B |
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 |
07182016A |
MIC Ultra Cocktail
Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 700mcg/Chromium Picolinate 20mcg/Pyridoxine HCL 2mg/ml |
06132016B, 08042016B,08252016A |
Mineral Mix Schrader
Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + Sodium Molybdate 250 mcg/ml + Strontium Chloride 1 mg/ml + Lithium Citrate 5 mg/ml + Chromium Picolinate 100 mcg/ml + Boron Citrate 1 798mg/ml + Sodium Selenite 200 mcg/ml + Cupric Sulfate 1 mg/ml |
05182016B, 08102016B |
Nandrolone Decanoate 200 mg/mL | 07112016A, 08172016B, 09122016C, 10252016E |
Pyridoxine HCL 100 mg/mL | 08162016A |
QuadMix | 05242016A |
Alprostadil/Phentolamine/Papaverine/Atropine
40mcg/2mg/40mg/0.04mg/mL |
|
QuadMix
Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/mL |
06162016B |
QuadMix
Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mcg/mL |
10262016H, 11032016C |
QuadMix
Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mcg/mL |
06072016F, 08112016C |
QuadMix
Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mcg/mL |
08102016F |
QuadMix
Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/mL |
07222016B |
QuadMix
Alprostadil/Phentolamine/Papaverine/Atropine 18mcg/1mg/1.8mg/0.02mg/mL |
07252016E, 07192016E, 07052016B, 09142016A |
Sermorelin Acetate 6 mg | 06062016D, 08022016A |
Sermorelin Acetate 9 mg | 08022016B |
Sermorelin Acetate 15 mg | 08152016B |
Sermorelin Forte 6 mg
Sermorelin Acetate 3 mg/GHRP-6 3 mg |
10192016A |
Sermorelin Forte 12 mg
Sermorelin Acetate 6 mg/GHRP-6 6 mg |
06152016C, 10242016C |
Sermorelin Forte Plus 18 mg
Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg |
05252016C, 07252016B, 09192016B |
Sermorelin Forte Plus 27 mg
Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg |
05252016B, 06232016B, 07152016B, 08262016D,
08152016A,08022016C, 09282016C, 10192016C, 10102016K, 10252016B |
Sermorelin GT
Sermorelin Acetate 15 mgGHRP-2 5.4 mg/Theanine (L) 75 mg |
06152016B, 07252016C, 08262016C, 09192016A,
10192016B, 10102016E, 10242016B |
Slim Shot
Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 1mg/Pyridoxine HCL 2.2mg/ml |
06292016A, 08102016C, 10262016C |
Taurine 50 mg/mL | 06282016C, 09062016C, 10242016A, 10212016A |
Testosterone Cypionate 100 mg/mL Sesame | 07152016A, 08182016A, 09282016J |
Testosterone Cypionate 150 mg/mL
Sesame |
05122016B, 08012016C, 09262016D |
Testosterone Cypionate 200 mg/mL
Grapeseed |
05232016D, 06162016A, 06132016A, 07282016I,
08172016D, 08042016C, 09222016F, 09062016A, 11012016L, 10272016B, 10252016D, 08252016B, 11022016C |
Testosterone Cypionate 200 mg/mL
Sesame Oil |
05252016A, 06272016B, 07262016D, 07182016H,
07182016G, 08252016C, 08222016B, 08102016A, 09282016D, 09222016E, 09152016A, 09062016B, 10252016C, 10042016E |
Testosterone Cypionate/Zinc Gluconate
200mg/2mg/mL Sesame Oil |
07262016A, 07132016C, 08302016A, 08042016D,
11012016K, 09202016D, 10032016B |
Testosterone Cypionate 250 mg/mL
Sesame Oil |
06272016A, 07252016A, 08242016A, 08112016B,
09212016B, 10252016L |
Testosterone Cypionate/Propionate
200mg/50mg/mL |
07132016D, 11072016B |
Testosterone Cypionate/Enanthate
180mg/20mg/mL |
07132016F |
Testosterone Cypionate/Enanthate/Propionate
160mg/20mg/20mg/mL |
06082016C, 06012016C, 07222016B, 08042016E,
09012016A, 10032016A |
Testosterone Enanthate 200 mg/mL
Sesame Oil |
05232016C, 07132016G, 08122016A, 09012016B,
11012016J, 09272016A |
Testosterone Suspension 100 mg/mL | 06292016C |
Testosterone Propionate 100 mg/mL | 07272016A, 07052016A, 10132016A, 11072016A |
Tri-Amino
Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/ml |
07262016F, 09152016E, 08092016A |
TriMix
Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL |
05312016D, 08312016C, 08162016F, 08032016E |
TriMix
Alprostadil/Phentolamine/Papaverine 10mcg/0.5mg/30mg/mL |
07152016C, 09292016A |
TriMix
Alprostadil/Phentolamine/Papaverine 10mcg/1mg/30mg/mL |
05312016A, 05182016E, 07292016B, 07212016A,
08012016F, 09272016H, 09072016C, 09012016C, 11012016C |
TriMix
Alprostadil/Phentolamine/Papaverine 20mcg/1mg/30mg/mL |
06152016D, 07272016D, 10252016I, 10202016A,
10172016A |
TriMix
Alprostadil/Phentolamine/Papaverine 20mcg/2mg/30mg/mL |
07152016E, 08012016G, 09162016B, 10112016C,
11032016B |
TriMix
Alprostadil/Phentolamine/Papaverine 20mcg/0.5mg/30mg/mL |
06012016E, 09272016B, 10032016G, 11012016D |
TriMix
Alprostadil/Phentolamine/Papaverine 30mcg/1mg/30mg/mL |
05232016E, 05192016B, 06092016C, 06132016F,
05022016E, 06292016D, 06232016D, 06222016E, 06202016B, 06162016B, 06152016E, 06132016C, 06082016E, 06072016D, 06022016C, 06012016D, 07282016F, 07262016G,07222016E, 07222016D,07202016A, 07192016D,07182016C, 07152016F, 07132016B, 07082016C, 07062016E, 08292016C, 08092016F, 08052016C, 08042016J, 08042016H, 08032016D, 08022016E, 09072016D, 09272016C, 10132016C, 11012016B |
TriMix
Alprostadil/Phentolamine/Papaverine 30mcg/0.5mg/10mg/mL |
06282016A, 06222016C, 07182016D, 10202016B,
11102016D |
TriMix
Alprostadil/Phentolamine/Papaverine 30mcg/1mg/10mg/mL |
06022016E |
TriMix
Alprostadil/Phentolamine/Papaverine |
07282016G, 07142016D, 07082016E, |
40mcg/2mg/60mg/mL | |
TriMix
Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL |
07112016B, 09232016S, 09222016H, 09072016E,
10252016F, 11032016F |
TriMix
Alprostadil/Phentolamine/Papaverine 100mcg/3mg/30mg/mL |
08022016F |
Ultra Amino Blend
Arginine HCL 150 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg + Glutamine (L) 75 mg/ml + Lidocaine HCL 10mg/mL |
06302016A, 06152016F, 08152016D |
Ultra Amino Energy Cocktail
Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Niacinamide 20mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 50mg/Chromium Picolinate 200mcg/Glutamine (L) 30mg/Arginine HCL 200mg/Lidocaine HCL 10mg/mL |
05232016B, 06082016B, 07272016C,
07152016H,08172016C, 09152016B, 10102016A, 11022016B, 10202016C |
Ultra Cocktail #2
Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/Riboflavin-5-Phosphate Sod 2mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 20mg/Chromium Picolinate 66mcg/Lidocaine HCL 10mg/mL |
05192016A, 05182016A, 08032016B, 09292016C,
08232016A |
Ultra Slim Shot
Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 1mg/Carnitine (L) 170mg/Pyridoxine HCL 2 mg/Lidocaine HCL 10mg/ml |
06232016C, 07272016B, 08232016B, 09202016C,
10262016D |
Vitamin D3 100,000 Unit/mL
Olive Oil |
06062016E, 07282016D, 08152016C, 09092016A,
10042016A |