Thursday, 19 January 2017 15:17

Recall Of Tri-Coast Pharmacy Sterile Products

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The Agency is notifying all healthcare providers of the voluntary recall launched by Tri Coast Pharmacy Inc. on all of its sterile products prepared between May 17, 2016 and November 17, 2016. The recalled products, used for a variety of indications, all carry a Tri-Coast Pharmacy Inc. label that includes the name, logo, drug name, lot number, and expiration date.

Reason for Recall

The recall was initiated as a result of the FDA’s concern that the conditions under which the drugs were produced introduce a lack of sterility assurance for the products.

Possible associated risks

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.

Affected product details

Product Lot number(s)
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

Healthcare provider’s action

All 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:

  • Discontinue the use of any products contained in the recall
  • Providers who have dispensed any sterile products prepared between May 17, 2016 and November 17, 2016 to a patient should make the patient(s) aware of this recall.

Healthcare providers and patients should report adverse events associated with the use of these products to the nearest NAFDAC office, NAFADC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

 

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