The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-978-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Methylcobalamin injections because FDA inspections found quality control issues that impacted 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterile injection) where sterility assurance is compromised, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Methylcobalamin injection solutions. The affected products include Methylcobalamin 1 mg/ml, 5 mg/ml, 10 mg/ml, and 25 mg/ml, as well as Methylcobalamin (PF) 1 mg/ml and 25 mg/ml. These sterile, prescription-only solutions are intended for intravenous and subcutaneous use only.

The recall was initiated following FDA inspectional findings that raised concerns regarding quality control procedures. Specifically, the inspection identified issues that impacted the assurance of sterility for the compounded products. The source text does not specify the number of units recalled or the specific distribution locations beyond the manufacturer's location.

Consumers and healthcare providers who have these products should stop using them and contact their pharmacist or the recalling firm for instructions on return or disposal. The source text does not report any specific illnesses or injuries associated with the use of these products.

The recalled product

Product
METHYLCOBALAMIN 1 mg/ml, 5 mg/ml, 10 mg/ml, 25 mg/ml and METHYLCOBALAMIN (PF) 1 MG/ML, 25 MG/ML INJ SOLN, 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 (11)

  • 04222013@14
  • 06052013@35
  • 07242013@8
  • 07242013@13
  • 04082013@11
  • 04292013@13
  • 02272013@9
  • 05212013@39
  • 03272013@28
  • 07032013@16
  • 02272013@8

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 failure

See all →

Similar recalls