D-0733-2023 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
- 13953 bags
Product Description
PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7025-1.
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 # 37-883074, Exp 04/28/2023; 37-883237, 37-883238, Exp 04/30/2023; 37-883940, Exp 05/02/2023; 37-884271, Exp 05/03/2023; 37-884749, 37-884751, Exp 05/05/2023; 37-885338, Exp 05/08/2023; 37-885756, Exp 05/09/2023; 37-886272, Exp 05/11/2023; 37-887512, Exp 05/16/2023; 37-888027, 37-888030, 37-888040, 37-888052, 37-888063, Exp 05/18/2023; 37-888314, Exp 05/21/2023; 37-890489, 37-890497, 37-890534, Exp 05/29/2023; 37-890933, Exp 05/30/2023; 37-891152, Exp 05/31/2023; 37-892985, 37-892986, 37-892995, Exp 06/07/2023; 37-893511, 37-893517, Exp 06/11/2023; 37-896481, Exp 06/21/2023; 37-897828, Exp 06/27/2023; 37-898523, Exp 06/29/2023