Compounded parenteral nutrition bags recalled over insufficiently documented cleaning step
Two bags of compounded Peripheral Parenteral Nutrition are being recalled because a daily cleaning step in the ISO-5 compounding area was not sufficiently documented.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall arising from a documentation gap in the cleaning record rather than any contamination or sterility failure found in the product.
Plain-English summary
Peripheral Parenteral Nutrition, a compounded sterile preparation supplied as a refrigerated single dose injection in 1440 mL and 1700 mL bags, prescription only, compounded by Central Admixture Pharmacy Services, Inc. of Los Angeles, is being recalled. The action covers 2 bags.
The stated reason is a lack of processing controls: the prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented. The FDA classified the action as Class II. The source does not report any contamination having been found.
Affected lots are 11-4785290-0-1, with a beyond use date of 6/19/2025 at 11:32 pm, and 11-4785217-0-1, with a beyond use date of 6/19/2025 at 10:25 pm. Distribution was in California.
Facilities should identify affected bags using the lot numbers above and follow the instructions issued by the compounder.
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.
- Category
- Drug — Compounded injectable
- Affected units
- 2
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:
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