D-0931-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 25, 2018
- Initiation Date
- June 12, 2018
- Termination Date
- January 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 420 bags
Product Description
EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25.
Reason for Recall
Lack of Assurance of Sterility: Potential leakage of bags.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 5/4/18 0300 58-85525P, BUD 6/18/2018; 5/10/18 1435 262-85525P, 5/10/18 1127 558-85525P, BUD 6/24/2018; 5/11/18 1327 457-85525P, BUD 6/25/2018; 5/14/18 0302 295-85525P, BUD 6/28/2018; 5/17/18 0500 558-85525P, BUD 7/1/2018; 5/24/18 1005 57-85525P, 5/24/18 1328 295-85525P, BUD 7/7/2018; 5/25/18 0302 295-85525P, BUD 7/9/2018; 5/30/18 0936 262-85525P, BUD 7/14/2018; 5/31/18 0805 558-85525P, BUD 7/17/2018.