Drug product
PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection, a) 1440 mL bag, b) 1700 mL bag, Central Admixture Pharmacy Services, Inc, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90870.
D-0530-2025
Product summary
- Event
- Event 97175
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 bags
- Official record key
drug-enforcement:D-0530-2025
Official wording
Reason: Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
Code information: Lot: a) 11-4785290-0-1, BUD: 6/19/2025 @ 11:32 pm; b) 11-4785217-0-1, BUD: 6/19/2025 @ 10:25 pm.
Distribution pattern: CA
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls