Class II · Moderate risk
Peripheral Parenteral Nutrition
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.
TPN bag (patient specific)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Incorrect Product Formulation: product did not contain insulin as listed in the label.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
- Recalling firm
- Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0524-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
All 2025 recallsOther cgmp deviation recalls from 2025
All cgmp deviation recalls
Class II · Moderate risk
Toothpaste: a) COLGATE
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Deodorant: a) Axe
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Petroleum jelly: a) Vaseline Petroleum Jelly
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Lucky Ice
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
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