D-1400-2014 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
- 170 mL
Product Description
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, 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: 2297, best used by 6/04/14; Lot: 2578, best used by 6/25/14; Lot: 2672, best used by 7/03/14; Lot: 3022, best used by 7/28/14; b) 10 mL: Lot: 2166, best used by 5/26/14; Lot: 2297, best used by 6/04/14; Lot: 2578, best used by 6/25/14