Parenteral Nutrition Compounded Sterile Injectable Recalled for Processing Control Deficiency
Central Admixture Pharmacy Services is recalling compounded parenteral nutrition injections due to inadequate documentation of cleaning procedures in the sterile compounding area. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (sterile injectable compounded preparation) where no injuries have been reported and the hazard is potential contamination due to processing control deficiency. FDA Class II classification without reported illnesses or hospitalizations does not mandate a higher score under the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. (CAPS) in Los Angeles is recalling compounded peripheral parenteral nutrition preparations in 1440 mL and 1700 mL bags due to processing control deficiencies identified during investigation. The recall affects products with lot numbers 11-4785290-0-1 and 11-4785217-0-1, with beyond-use dates of June 19, 2025.
The recall was initiated because investigations identified that a daily cleaning procedure in the ISO-5 compounding area where these preparations were made was not sufficiently documented. Adequate documentation of sterilization and cleaning procedures is critical to ensure the safety of sterile injectable preparations, and the lack of such documentation represents a potential risk of contamination.
This product was distributed in California. Patients currently receiving this product and healthcare providers should contact their pharmacy or healthcare provider regarding this recall. While no illnesses or injuries have been reported to date, anyone who has received doses of this product should be aware of this recall and consult their healthcare provider with any questions or concerns.
The recalled product
- 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.
- Manufacturer
- Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
- Category
- Drug — Compounded Injectable
- Hazard
- contamination-risk
- processing-control-deficiency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distributed in 1 state:
- CA
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