The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-939-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls B-Complex/Lidocaine Injection Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling B-Complex/Lidocaine 2% Injection 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, and the hazard involves a lack of sterility assurance in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling B-Complex/Lidocaine 2% Injection. The recall covers all presentations of the sterile, prescription-only medication intended for intravenous and subcutaneous use only. The product was distributed nationwide in the United States.

The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings identified concerns associated with quality control procedures that impacted the assurance of sterility for the compounded medication.

Patients and healthcare providers who have received or administered this product should contact their healthcare provider or the recalling firm for further instructions on how to proceed. Consumers should not use the recalled product until further notice.

The recalled product

Product
B-COMPLEX/LIDOCAINE 2% INJECTION, 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 (1)

  • 04222013@23

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 →

Related recalls

Same manufacturer · Beacon Hill Medical Pharmacy, P.C.

See all →

Same hazard · sterility

See all →

Similar recalls