Drug product
PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6058-1.
D-0715-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6407 bags
- Official record key
drug-enforcement:D-0715-2023
Official wording
Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Code information: Lot # 37-884272, Exp 05/03/2023; 37-887513, Exp 05/16/2023; 37-888083, Exp 05/18/2023; 37-889123, 37-889423, Exp 05/23/2023; 37-891563, Exp 06/01/2023; 37-892577, 37-892582, Exp 06/06/2023; 37-893248, 37-893257, Exp 06/08/2023; 37-894436, Exp 06/13/2023; 37-895805, Exp 06/19/2023; 37-898324, Exp 06/28/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility