Class III · Low risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect Product Formulation
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Incorrect product formulation: bag did not contain copper and famotidine per 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
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767.
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0618-2026 · 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.
All 2026 recalls
Class I · High risk
PHENYLephrine added to 0.9% sodium chloride
Presence of Particulate Matter
Class II · Moderate risk
HYDROmorphone in dextrose 5%
Lack of assurance of sterility:
Class II · Moderate risk
HYDROmorphone in 0.9% Sodium Chloride
Lack of assurance of sterility:
Other cgmp deviation recalls from 2026
All cgmp deviation recalls
Class II · Moderate risk
Broadway Joe's Pain Cream
CGMP Deviations: Potential contamination of raw material
Class II · Moderate risk
Broadway Joe's Pain Cream
CGMP Deviations: Potential contamination of raw material
Class II · Moderate risk
Menow Sunscreen Pressed Powder Spf35 PA+++
cGMP Deviations
Class II · Moderate risk
Carbamazepine Tablets
CGMP deviations: tablets with black specks.
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