The Recall Desk
HighFDA (Drugs)·D-0269-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Lipo-C Vials Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 69 vials of Lipo-C compounded between May and November 2016 because the agency could not ensure the products were 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 injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Tri-Coast Pharmacy is recalling 69 vials of Lipo-C, a compounded sterile product containing methionine, inositol, choline chloride, and other ingredients. The recall covers all sterile products compounded by the pharmacy between May 17, 2016, and November 17, 2016. The specific reason for the recall is a lack of assurance of sterility.

The recall is classified as Class II by the U.S. Food and Drug Administration. The affected products were distributed nationwide. Known lot codes for the recalled items are 07282016B and 08242016B, both with an expiration date of December 31, 2016.

Consumers and healthcare providers should stop using the affected Lipo-C vials immediately. The source text does not provide specific instructions for disposal or return, but users should contact their healthcare provider or the recalling firm for guidance on next steps.

The recalled product

Product
Lipo-C (Methionine 25 mg/Inositol 50 mg/Choline Chloride 50 mg/Carnitine (L) 100 mg/Methylcobalamin 1 mg/Thiamine HCL 50 mg/Rivoflavin-5-Phosphate Sod 5 mg/Niacinamide 50 mg/Dexpanthenol 5 mg/Pyridoxine HCL 1.25 mg/Lidocaine HCL 10 mg/mL), (30 ML). Compounded by Tri-Coast Pharmac
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
69

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 (1)

  • 08242016B (12/31/2016)

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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