FDA (Drugs) recall action 68557

John W Hollis Inc recalled 19 products on 2014-06-25

The FDA (Drugs) publishes a recall like this one as 19 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 19 pages.

Products: 19
Announced: 2014-06-25
Critical: 0
Units: —

Why these products were recalled

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

The agency’s own wording, quoted from the enforcement report.

1–19 of 19

SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls Liver Derivative Complex Injection for Sterility Concerns
John W Hollis Inc is recalling specific lots of Liver Derivative Complex for injection due to a lack of assurance of sterility in the compounded aseptically filled products.
Product
Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex 25.5mg, also contains: Water for Injection, Phenol 0.5%, HCl or NaOH to adjust pH, 10 mL, Compounded by Prescription: JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-32
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls Compounded Injectable Products Due to Sterility Concerns
John W Hollis Inc is recalling compounded injectable products containing papaverine, phentolamine, and alprostadil due to a lack of assurance of sterility.
Product
Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls Methylcobalamin Injectable Due to Sterility Concerns
John W Hollis Inc is recalling Methylcobalamin 1000 mcg injectable products because they lack assurance of sterility. The recall covers Lot # 1862 distributed nationwide.
Product
METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1000 mcg, Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls Cyanocobalamin Injection Due to Sterility Concerns
John W Hollis Inc is recalling specific lots of Cyanocobalamin injection because the products lack assurance of sterility. The recall covers 2,650 mL distributed nationwide.
Product
CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: Cyanocobalamin 1000 mcg, , Also Contains: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 6
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Recalls Polidocanol Injection Due to Sterility Concerns
John W Hollis Inc is recalling Polidocanol 0.5% Solution for Injection because the products lack assurance of sterility.
Product
Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Recalls Polidocanol 1% Injection Due to Sterility Concerns
John W Hollis Inc. is recalling Lot 2868 of Polidocanol 1% Solution for Injection because the company cannot ensure the product is sterile.
Product
Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 B2 Avenue N, Nashville, TN 37203, 615-327-3234
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls Compounded Injectable Drug Due to Sterility Concerns
John W Hollis Inc is recalling a compounded injectable drug product due to a lack of assurance of sterility. The product is distributed nationwide.
Product
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Recalls Levocarnitine Injection Due to Sterility Concerns
John W Hollis Inc. is recalling Levocarnitine Solution for injection because the company cannot ensure the product is sterile. The recall covers specific lots distributed nationwide.
Product
Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls Pyridoxine HCl Injectable Due to Sterility Concerns
John W Hollis Inc is recalling Pyridoxine HCl 100mg injectable products because they lack assurance of sterility. Consumers should stop using the product and contact their pharmacist.
Product
PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
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Distribution
0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls Compounded Injectable Products Due to Sterility Concerns
John W Hollis Inc is recalling specific lots of compounded injectable products containing papaverine, phentolamine, and alprostadil due to a lack of sterility assurance.
Product
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
Category
Distribution
0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls Compounded Injectable Products Due to Sterility Concerns
John W Hollis Inc is recalling compounded injectable products containing papaverine, phentolamine, and alprostadil due to a lack of sterility assurance.
Product
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203 615-327-3234
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Distribution
0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls Lipotropic Gold Injectable Due to Sterility Concerns
John W Hollis Inc is recalling 80 mL vials of Lipotropic Gold injectable products because they may lack sterility assurance.
Product
LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate 5 mg, Cyanocobalamin 1mg, Methionine 12.5mg, Choline 25mg, Inositol 25 mg, Sterile Water For injection, JOHN HOLLIS Pharmacist, Inc,110 20th A
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Recalls Polidocanol 5% Injection Due to Sterility Concerns
John W Hollis Inc is recalling Polidocanol 5% Solution for Injection because the company cannot ensure the product is sterile.
Product
Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL Vial, JOHN HOLLIS Pharmacist Inc, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls B-Complex/Adenosine Injectable Solution for Sterility Concerns
John W Hollis Inc is recalling B-Complex/Adenosine Injectable Solution due to a lack of sterility assurance in the compounded aseptically filled products.
Product
B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobalamin 0.3mg, Inositol 0.05g, Methionine 0.015g, Levocarnitine 0.1g, Chromic Chloride 0.15g, Lidocaine HCl 0.01g, Pyrodoxine HCl 0.005g, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Aven
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls Compounded Injectable Drugs Due to Sterility Concerns
John W Hollis Inc is recalling compounded Papaverine HCl and Phentolamine Mesylate injectable products due to a lack of assurance of sterility.
Product
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls Testosterone Cypionate Injection Due to Sterility Concerns
John W Hollis Inc is recalling specific lots of Testosterone Cypionate for Injection because the products lack assurance of sterility.
Product
Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate 200 mg, also contains: Cotton Seed Oil, Benzyl Benzoate, Benzyl Alcohol, Rx Only, 10 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Recalls Mannitol 5% Solution for Injection Due to Sterility Concerns
John W Hollis Inc. is recalling specific lots of Mannitol 5% Solution for injection because the products lack assurance of sterility.
Product
Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water for Injection, Chlorobutanol USP, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls Compounded Injectable Products Due to Sterility Concerns
John W Hollis Inc is recalling specific lots of compounded injectable products containing papaverine, phentolamine, and alprostadil due to a lack of assurance of sterility.
Product
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
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0 states
SevereFDA (Drugs)··2014-06-25
John W Hollis Inc Recalls MIC Plus B12 Injectable Due to Sterility Concerns
John W Hollis Inc is recalling MIC Plus B12 injectable vials because the products lack assurance of sterility. Consumers should stop using the affected lots immediately.
Product
MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100mg, Inositol 50mg, B 12, 0.200mg, Adenosine 20mg, L-Carnitine 30mg/ML, 30ML MULTI DOSE VIAL, BENZYL ALCOHOL AS A PRESERVATIVE, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-32
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