Beacon Hill Medical Pharmacy Recalls B-12/Lidocaine Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling B-12/Lidocaine 25/10mg/mL injections because FDA inspections raised concerns about sterility assurance and quality control.
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 rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe (Score 4), as they are not Class I (Critical) but involve significant risk factors.
Plain-English summary
Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling all presentations of B-12/LIDOCAINE 25/10MG/ML. This sterile, prescription-only medication is intended for intravenous and subcutaneous use only. The recall is being conducted due to FDA inspectional findings that resulted in concerns associated with quality control procedures that impacted sterility assurance.
The product was distributed nationwide in the United States. The recall is classified as FDA 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 and healthcare providers who have this product should stop using it and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication. Patients who have already received the injection should consult their healthcare provider if they have concerns or experience any adverse effects.
The recalled product
- Product
- B-12/LIDOCAINE 25/10MG/ML, 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.
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 (1)
- 01092013@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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