Home / Recalls / John W Hollis Inc / D-1397-2014

D-1397-2014 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
365 mL

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

a) 5 mL: Lot: 2319, best used by 6/04/14; Lot: 2510, best used by 6/22/14; Lot: 2576, best used by 6/25/14; Lot: 2624, best by 6/30/14; Lot: 2744, best used by 7/08/14; Lot: 3048, best used by 7/30/14; Lot: 3062, best used by 7/31/14; Lot: 3106, best used by 8/6/14; b) 10 mL: Lot 2084, best used by 5/19/14; Lot 2318, best used by 6/04/14; Lot: 2369, best used by 6/10/04; Lot: 2396, best used by 6/11/14; Lot: 2576, best used by 6/25/14; Lot: 2744, best used by 7/08/14; Lot: 3062, best used by 7/31/14; Lot: 3106, best used by 8/6/14; Lot: 3123, best used by 8/10/14

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)