Tri-Coast Pharmacy Voluntarily Recalling Sterile Products Prepared Due to Concern Over Lack of Sterility Assurance

Tuesday, November 22, 2016

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 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

 

 

 

 

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