PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated Injection, Rx Only, Single Dose Injection,
Summary
The FDA issued a Class II for PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated In by Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles. 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 do.
Details
Source
Drug Recall
External ID
D-0530-2025
Action Date
2025-07-23
Status
Ongoing
Category
drug
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.
Lot/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.
Quantity Affected: 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.
Distribution
CA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-01
Company
Santa Fe Springs, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 51 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles have FDA actions?
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0530-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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