Tri-Coast Pharmacy Recalls Lipotropic Injections Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 987 vials of compounded Lipotropic injections nationwide because the agency could not ensure the products were 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 identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a risk of harm (lack of sterility) where injury has not yet been reported is classified as Severe (Score 4).
Plain-English summary
Tri-Coast Pharmacy is voluntarily recalling 987 vials of compounded Lipotropic injections (30 mL) distributed nationwide. The recall was initiated due to a lack of assurance of sterility for the sterile products.
The affected product contains L-Carnitine, Methylcobalamin, Thiamine HCL, Riboflavin-5-phosphate Sod, Niacinamide, Pyridoxine HCL, Folic Acid, and Lidocaine HCL. The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Known lot codes include 09022016A (expiration date 12/31/2016) and 07282016C (expiration date 12/31/2016).
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 987
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)
- 07282016C (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.
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