D-0870-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 7, 2017
- Initiation Date
- May 18, 2017
- Termination Date
- March 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 bags
Product Description
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.
Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Distribution Pattern
Nationwide in the USA
Code Information
LOT # 20170508@57, Use By: 08/06/17