Guardian Pharmacy Recalls MIC B Combo Lipotropic Vials for Sterility Concerns
Guardian Pharmacy Services is recalling 250 vials of MIC B Combo Lipotropic in Texas due to a lack of sterility assurance.
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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly when the hazard involves sterility assurance which carries a risk of infection.
Plain-English summary
Guardian Pharmacy Services is recalling 250 50-ml vials of MIC "B" Combo Lipotropic. The product is packaged in 50ml MDV vials and was distributed in Texas. The specific lot number is 58618:42 UB, with a use-by date of 06/10/2018.
The recall was initiated due to a lack of sterility assurance. 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 purchased this product should stop using it and contact Guardian Pharmacy Services for further instructions or a refund.
The recalled product
- Product
- MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Manufacturer
- Guardian Pharmacy Services
- Category
- Drug — Compounded Injectable
- Hazard
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)
- Lots: 58618:42 UB
- Use By: 06/10/2018
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 23 recalled by Guardian Pharmacy Services 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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