Home / Recalls / John W Hollis Inc / D-1391-2014

D-1391-2014 Class II Terminated

Recalled by John W Hollis Inc — Nashville, TN

Recall Details

Product Type: Drugs
Report Date: June 25, 2014
Initiation Date: May 12, 2014
Termination Date: July 2, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 550 mL

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot 1076, use by 08/28/14; Lot 2410, use by 09/13/14; Lot 2746, use by 10/06/14

Other recalls by John W Hollis Inc

D-1398-2014 Class II — B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0 (May 12, 2014)
D-1406-2014 Class II — Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) (May 12, 2014)
D-1394-2014 Class II — Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Water (May 12, 2014)
D-1395-2014 Class II — Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile W (May 12, 2014)
D-1389-2014 Class II — Liver Derivative Complex for injection, each mL contains: Liver Derivative Compl (May 12, 2014)
D-1390-2014 Class II — CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: Cy (May 12, 2014)
D-1399-2014 Class II — Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL an (May 12, 2014)
D-1393-2014 Class II — MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100mg, (May 12, 2014)
D-1401-2014 Class II — Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, JOH (May 12, 2014)
D-1402-2014 Class II — Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 mL (May 12, 2014)