FDAFDA · Food and drugs·Recall number D-1399-2014
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
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: 2543, best used by 3/24/14; Lot: 2137, best used by 5/25/14; Lot 3056, best used by 7/30/14; Lot: 3081, best used by 8/04/14; b) 10 mL: Lot: 2194, best used by 5/26/14; Lot: 2950, best used by 7/22/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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