Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives:...

FDA Drug Recall #D-470-2015 — Class I — December 17, 2014

Recall Summary

Recall Number D-470-2015
Classification Class I — Serious risk
Date Initiated December 17, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Central Admixture Pharmacy Services, Inc.
Location Allentown, PA
Product Type Drugs
Quantity 12 bags

Product Description

Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.

Reason for Recall

Non-Sterility: Out of specification results for the sterility test for microbial contamination.

Distribution Pattern

Nationwide

Lot / Code Information

lot number 37-74714, Made on 15 DEC 2014, EXP 24 DEC 2014, CAPS Rx: 37-74714-0-12-R, Disp ID: 37-1124493

Other Recalls from Central Admixture Pharmacy Services, ...

Recall # Classification Product Date
D-0272-2025 Class I PHENYLephrine added to 0.9% sodium chloride, 40... Feb 20, 2025
D-1117-2023 Class II Neonatal TPN Starter Bag, Amino Acids (trophami... Aug 17, 2023
D-1130-2023 Class II EPINEPHrine added to 0.9% sodium chloride, 4mg/... Aug 17, 2023
D-1111-2023 Class II Cardioplegia Solution, low K, Maintenance 4:1 P... Aug 17, 2023
D-1138-2023 Class II dilTIAZem 125mg/125mL (1 mg/mL), added to dextr... Aug 17, 2023

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.