The Recall Desk
SevereFDA (Drugs)·D-0263-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls HCG Vials Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 5,229 HCG 11,000 IU vials nationwide because the FDA cannot ensure the products are sterile.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility, which poses a risk of serious health consequences such as infection, meeting the criteria for a Severe rating.

Plain-English summary

Tri-Coast Pharmacy is recalling 5,229 vials of HCG 11,000 IU compounded by the pharmacy. The recall is being conducted because there is a lack of assurance that the sterile products are actually sterile.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The distribution pattern is nationwide. Specific lot codes and expiration dates are listed in the official recall documentation.

Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
HCG 11,000 IU Vial. Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Products
Hazard
Affected units
5,229

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 (14)

  • 07252016D (01/21/2017)
  • 07112016C (01/07/2017)
  • 08312016B (02/27/2017)
  • 08262016B (02/22/2017)
  • 08092016D (02/05/2017)
  • 08052016A (02/01/2017)
  • 09282016B (02/28/2017)
  • 09222016D (02/28/2017)
  • 09072016A (02/28/2017)
  • 10252016J (02/28/2017)
  • 10182016D (02/28/2017)
  • 10102016H (02/28/2017)
  • 11042016A (02/28/2017)
  • 11012016E (02/28/2017)

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 →

Related recalls

Same manufacturer · Tri-Coast Pharmacy

See all →

Same hazard · lack of sterility

See all →