The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1010-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Vitamin D Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Vitamin D 50,000 I.U./ML Injectable due to FDA inspectional findings regarding sterility assurance and quality control.

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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of sterility failure in an injectable medication.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C. is recalling all configurations of Vitamin D 50,000 I.U./ML Injectable, which is intended for intravenous and subcutaneous use only. The product was compounded by Beacon Hill Medical Pharmacy PC, doing business as Rxtra Solutions, in Southfield, Michigan.

The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures impacting the assurance of sterility. The source text does not specify the number of units affected, specific lot numbers beyond the provided codes, or the exact distribution dates.

Patients who have received this medication should contact their healthcare provider for guidance. The source text does not provide specific instructions for consumers on how to return the product or manage potential side effects.

The recalled product

Product
VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, 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 — 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 (2)

  • 03082013@20
  • 07032013@15

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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