D-0744-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2023
- Initiation Date
- April 28, 2023
- Termination Date
- June 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6414 bags
Product Description
NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8096-1.
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot # 37-882989, Exp 04/28/2023; 37-883827, 37-883829, 37-883830, 37-883833, 37-883858, Exp 05/02/2023; 37-884758, Exp 05/05/2023; 37-885357, Exp 05/08/2023; 37-885748, 37-885751, Exp 05/09/2023; 37-887409, 37-887410, Exp 05/16/2023; 37-888863, 37-888867, Exp 05/22/2023; 37-889226, Exp 05/23/2023; 37-889576, 37-889577, Exp 05/24/2023; 37-889804, 37-889817, 37-889830, Exp 05/25/2023; 37-891280, Exp 05/31/2023; 37-891758, 37-891759, Exp 06/04/2023; 37-894311, 37-894315, 37-894319, Exp 06/13/2023; 37-895304, Exp 06/18/2023; 37-896544, 37-896545, 37-896546, 37-896552, Exp 06/21/2023; 37-898514, 37-898515, 37-898516, Exp 06/29/2023; 37-899305, Exp 07/03/2023; 37-900362, Exp 07/06/2023