D-1403-2014 Class II Terminated
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
- 40 mL
Product Description
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
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: 2670 best used by 7/02/14; Lot 2855, best used by 7/15/14; b) 10 mL: Lot: 2303, best used by 6/04/14; Lot: 2343, best used by 6/08/14; Lot: 2600, best used by 6/29/14;