Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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

For Immediate Release

November 18, 2016

Contact

Consumers

Tri-Coast Pharmacy Inc.
pharmacist@tricoastrx.com

 

Announcement

Juno Beach, FL – Tri-Coast Pharmacy Inc. is voluntarily recalling all sterile products prepared between May 17, 2016 and November 17, 2016 and that remain within expiry (list is attached below) due to Food and Drug Administration’s (“FDA”) concerns over the lack of sterility assurance of the drugs named in this recall.

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 Suspension05312016C, 06292016B, 06282016E, 06082016F,
07142016B, 09272016F, 10182016B
Adenosine-5 Monophosphate 100 mg/mL08052016B
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% Injection08172016A
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/mL08162016B
GAC
L-Glutamine/L-Arginine/L-Carnitine
25mg/100mg/200mg/mL
06172016A, 08092016B, 09262016A, 10132016E
Glucosamine 200 mg/mL10192016D
Glutamine 25 mg/mL08032016A
Glutathione 200 mg/mL06082016A, 07052016C, 08082016A, 09132016D,
10262016A
HCG 5,000 IU Vial06222016D, 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 Vial06152016A, 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/mL07282016H, 09282016E
L-Carnitine 250 mg/mL09132016F
L-Tyrosine 10 mg/mL07292016A, 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/mL05132016KK, 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/mL07112016A, 08172016B, 09122016C, 10252016E
Pyridoxine HCL 100 mg/mL08162016A
QuadMix05242016A
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 mg06062016D, 08022016A
Sermorelin Acetate 9 mg08022016B
Sermorelin Acetate 15 mg08152016B
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/mL06282016C, 09062016C, 10242016A, 10212016A
Testosterone Cypionate 100 mg/mL Sesame07152016A, 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/mL06292016C
Testosterone Propionate 100 mg/mL07272016A, 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
 

 

 

 

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