TPN Bag Recalled for Missing Insulin Formulation Error
Central Admixture Pharmacy Services is recalling a patient-specific TPN bag because it did not contain insulin as listed on the label. Patients relying on this product for the labeled insulin dosage may face serious health risks.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II recall with a significant formulation error—missing a critical pharmaceutical component (insulin) from a parenteral nutrition product used in high-risk clinical settings. The absence of a labeled medication in a compounded injection poses serious risk of harm to patients dependent on the declared formulation.
Plain-English summary
Central Admixture Pharmacy Services, Inc (CAPS) in Los Angeles is recalling a patient-specific TPN (Total Parenteral Nutrition) bag, Rx# 11-4909703-0-1, Lot #11-4909703-0-1, with expiration date 12/28/2025. The product was labeled as containing insulin, but the compounded bag does not contain insulin.
The product, a 1660 mL refrigerated single-dose injection, was distributed in California. Patients who received this TPN bag were expecting the labeled insulin dose as part of their nutrition support therapy.
Patients who have received this product should contact their healthcare provider immediately to confirm whether they received the affected bag and to discuss appropriate medical management. Healthcare providers should review patient records and contact affected patients directly if this product was dispensed to them.
The recalled product
- Product
- TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670
- Affected units
- 1
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 (2)
- Lot #: 11-4909703-0-1
- Exp 12/28/2025
Distribution
Distributed in 1 state:
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