The Recall Desk
SevereFDA (Drugs)·D-0259-2017·Announced 2017-01-11

FDA Recalls Tri-Coast Pharmacy Glutamine Due to Sterility Concerns

Tri-Coast Pharmacy is recalling compounded Glutamine 25 mg/mL vials nationwide because the agency cannot assure 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 in a compounded drug, which poses a risk of serious health consequences such as infection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Glutamine 25 mg/mL (30 ML) compounded by Tri-Coast Pharmacy. The recall covers 12 vials distributed nationwide. The specific reason for the recall is a lack of assurance of sterility.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. One known lot code is 08032016A, which has an expiration date of January 30, 2017. The FDA has classified this recall as Class II.

Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions. The recall is being conducted by Tri-Coast Pharmacy.

The recalled product

Product
Glutamine 25 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
12

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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