The Recall Desk
HighFDA (Drugs)·D-0264-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Infuvite IV Vials Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 161 vials of Infuvite IV compounded between May and November 2016 because the agency cannot assure the products are sterile.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility failure) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for theoretical or unreported harm risks.

Plain-English summary

Tri-Coast Pharmacy is recalling 161 vials of Infuvite IV, a compounded sterile product containing ascorbic acid and various vitamins. The recall covers all sterile products compounded by the pharmacy between May 17, 2016, and November 17, 2016.

The recall was initiated due to a lack of assurance of sterility. The FDA has classified this as a Class II recall. The affected products were distributed nationwide.

Consumers and healthcare providers should stop using the recalled vials and contact their pharmacist or healthcare provider for further instructions. Specific lot codes associated with the recall include 07062016D, 08312016A, 08232016C, 08222016C, 08102016E, 08102016D, 08012016E, 09262016C, and 09132016C.

The recalled product

Product
Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL). 30 ML. Compounded by Tri-Coast
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
161

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 (9)

  • if known): 07062016D (10/30/2016)
  • 08312016A
  • 08232016C
  • 08222016C
  • 08102016E
  • 08102016D
  • 08012016E
  • 09262016C
  • 09132016C

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 80 recalled by Tri-Coast Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 80 products in this recall →

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Same hazard · sterility failure

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