FDAFDA · Food and drugs·Recall number D-1397-2014
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
Published June 25, 2014 · Recall initiated: May 12, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- John W Hollis Inc
- Distributor
- Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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