The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-980-2013·Announced 2013-09-18

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.

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. 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
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)

  • 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.

See all 86 products in this recall →

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