The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-942-2013·Announced 2013-09-18

FDA Recalls Bi-Tropin S-2 Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Bi-Tropin S-2 Injectable due to FDA inspectional findings regarding 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 source text identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a sterile injectable product where sterility assurance is compromised is classified as Severe (Score 4), as it carries a risk of significant injury or infection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Bi-Tropin S-2 Injectable, all presentations, compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, in Southfield, Michigan. The product is intended for intravenous and subcutaneous use only and is available by prescription.

The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures. Specifically, the findings impacted the assurance of sterility for the compounded product. The recall covers batches with the following codes: 01242013@2, 04172013@8, 05242013@7, and 07152013@9.

The product was distributed nationwide in the United States. Patients who have received this medication should contact their healthcare provider or pharmacist for guidance on next steps. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
BI-TROPIN S-2 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 (4)

  • 01242013@2
  • 04172013@8
  • 05242013@7
  • 07152013@9

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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