Tri-Coast Pharmacy Recalls Lipotropic with MIC Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 236 vials of Lipotropic with MIC compounded between May and November 2016 due to a lack of assurance of sterility.
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. According to the severity rubric, an FDA Class II recall involving a significant risk such as lack of sterility in a sterile product corresponds to a score of 4 (Severe).
Plain-English summary
Tri-Coast Pharmacy is recalling 236 vials of a compounded medication known as Lipotropic with MIC. The product contains a mixture of ingredients including Methionine, Inositol, Choline Chloride, L-Carnitine, Methylcopalamin, Thiamine HCL, Riboflavin-5-Phosphate Sod, Niacinamide, Pyridoxine HCL, Folic Acid, and Lidocaine HCL. The recall is being conducted because of a lack of assurance of sterility in the compounded products.
The recall includes all sterile products compounded by Tri-Coast Pharmacy between May 17, 2016, and November 17, 2016. Specific lot codes identified in the recall are 06012016B (expiration date 11/28/2016), 07082016A (expiration date 12/31/2016), and 08242016C (expiration date 12/31/2016). The affected products were distributed nationwide.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. 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.
The recalled product
- Product
- Lipotropic with MIC (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/L-Carnitine 170 mg + Methylcopalamin 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 20mg/ml, (30 ML). Compound
- Manufacturer
- Tri-Coast Pharmacy
- Hazard
- Affected units
- 236
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 (2)
- 07082016A (12/31/2016)
- 08242016C (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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