Tri-Coast Pharmacy Recalls Glucosamine Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 30 vials of compounded Glucosamine 200 mg/mL 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe).
Plain-English summary
Tri-Coast Pharmacy is recalling 30 vials of compounded Glucosamine 200 mg/mL (30 ML) due to a lack of assurance of sterility. The recall includes all sterile products compounded by the pharmacy between May 17, 2016, and November 17, 2016. One known lot code is 10192016D, with an expiration date of October 22, 2016.
The products were distributed nationwide. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers who have these products should stop using them and contact Tri-Coast Pharmacy for further instructions or a refund.
The recalled product
- Product
- Glucosamine 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Hazard
- Affected units
- 30
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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