Drug product
phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 mcg/mL*, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7039-1.
D-0735-2023
Product summary
- Event
- Event 92253
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1735 bags
- Official record key
drug-enforcement:D-0735-2023
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 # 37-887056, 37-887057, 37-887059, Exp 05/15/2023; 37-893807, Exp 06/12/2023; 37-896880, Exp 06/22/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility