Northwest Compounding Pharmacy Recalls MIC B Vitamin Liquid for Sterility Concerns
Northwest Compounding Pharmacy is recalling MIC B vitamin liquid due to a lack of sterility assurance. The product was distributed in Oregon to medical facilities and patients.
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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance in injectable/liquid medications) are categorized as Severe (Score 4), as they are not Class I (Critical) but represent a significant risk.
Plain-English summary
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is recalling MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vials. The recall is being conducted because of a lack of sterility assurance in the product.
The affected product was distributed exclusively in the state of Oregon. Distribution included 3 medical facilities, 1 physician's office, and 80 consumers or patients. The product is a compounded medication, meaning labels vary for each specific patient compound, and the firm did not provide specific labeling details for the recall notice.
Consumers and medical facilities should stop using the product and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA 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
- MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
- Category
- Drug — Compounded Medication
- 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 (3)
- 1) 10192018@8 exp 2/28/19
- MIC Ba w/ aminos 2) 10292018@15 exp 1/31/19
- MIC B
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 17 recalled by Hiers Enterprises, LLC dba Northwest Compounding 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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