D-1004-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 2, 2017
- Initiation Date
- July 14, 2017
- Termination Date
- October 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 bags
Product Description
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.
Reason for Recall
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 20170710@3, BUD: 10/8/2017