Tri-Coast Pharmacy Recalls MIC Ultra Cocktail Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 278 vials of MIC Ultra Cocktail nationwide due to a lack of assurance of sterility.
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 injectable product, which presents a significant risk of infection or serious injury.
Plain-English summary
Tri-Coast Pharmacy is voluntarily recalling 278 vials of MIC Ultra Cocktail, a compounded sterile product containing methionine, inositol, choline chloride, methylcobalamin, chromium picolinate, and pyridoxine HCL. The recall is being conducted because of a lack of assurance of sterility for the affected products.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The distribution pattern is nationwide. Specific lot codes identified in the recall include 06132016B (expiration date 11/30/2016), 08042016B (expiration date 12/31/2016), and 08252016A (expiration date 12/31/2016).
Consumers and healthcare providers who have purchased or received this product should stop using it and contact their pharmacist or the recalling firm 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.
The recalled product
- Product
- MIC Ultra Cocktail (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 700mcg/Chromium Picolinate 20 mcg/Pyridoxine HCL 2mg/ml), (10 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Affected units
- 278
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)
- 08042016B (12/31/2016)
- 08252016A (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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