Beacon Hill Medical Pharmacy Recalls MIC-CARN Injectable Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling MIC-CARN + B6/B12/LIDOCAINE injectable products because FDA inspections raised concerns about quality control and 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectables) are classified as Severe (Score 4), particularly when no specific hospitalization reports are present to elevate it to Critical, but the risk is significant enough to warrant a high severity rating.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C. is recalling all presentations of MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0.1MG/ML INJECTABLE. The product is compounded for intravenous and subcutaneous use only and is available by prescription. The recall is being conducted due to FDA inspectional findings that resulted in concerns associated with quality control procedures impacting sterility assurance.
The recall covers products distributed nationwide in the United States. The source text does not specify the exact number of units affected or specific lot numbers beyond the code information provided in the metadata. No illnesses or injuries have been reported in the source text.
Patients who have received this medication should contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a situation where 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.
The recalled product
- Product
- MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0.1MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Manufacturer
- Beacon Hill Medical Pharmacy, P.C.
- Category
- Drug — Compounded Injectable
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)
- 02142013@6
- 05022013@15
- 07192013@13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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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