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Recall Observatory FDA recall evidence

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

July 01, 2025

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
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

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls