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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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.
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