Drug Enforcement D-0530-2025

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.

Status

Ongoing

Classification

Class II

Report Date

July 23, 2025

Termination Date

Product Information

Product description
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.
Product quantity
2 bags
Reason for recall
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.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
CA

Location & Firm

Recalling firm
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
Address
13128 Imperial Hwy, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0530-2025
Event ID
97175
Recall initiation date
July 1, 2025
Center classification date
July 16, 2025
Code info
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.
More code info