The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1008-2013·Announced 2013-09-18

FDA Recalls Triptropin Plus Injectable Due to Sterility Assurance Concerns

Beacon Hill Medical Pharmacy is recalling Triptropin Plus Injectable because FDA inspections raised concerns about quality control procedures 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 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 involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Triptropin Plus Injectable, compounded by Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions) in Southfield, Michigan. The recall covers all configurations of the sterile, prescription-only injectable intended for intravenous and subcutaneous use.

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 sterility assurance of the product. The affected lots were distributed nationwide in the United States.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions. The specific lot codes associated with this recall are listed in the official FDA documentation.

The recalled product

Product
TRIPTROPIN PLUS 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 (13)

  • 07022013@37
  • 01152013@32
  • 03012013@22
  • 03062013@15
  • 03122013@14
  • 04102013@4
  • 04242013@14
  • 04302013@2
  • 05242013@9
  • 06122013@26
  • 06122013@20
  • 07112013@16
  • 07232013@2

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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