The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-997-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Sermorelin Acetate Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Sermorelin Acetate 10 mg injectable because FDA inspectional findings raised concerns about 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 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 is classified as FDA Class II and involves a risk-of-harm product (sterility failure in an injectable) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Sermorelin Acetate 10 mg injectable. The product is compounded for intravenous and subcutaneous use only and is sterile, prescription-only medication. The recall covers all presentations of the product distributed nationwide in the United States.

The recall was initiated due to lack of assurance of sterility. FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. The agency classified this recall as Class II.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for instructions on return or disposal. The specific lot codes affected include 03182013@6, 03282013@26, 01142013@2, 01182013@2, 01172013@15, 02192013@3, 03062013@8, 04102013@3, 04262013@11, 05142013@35, 05212013@20, 5212013@17, 05242013@6, 06082013@3, 06072013@10, 06182013@27, 06292013@1, 07132013@2, 07232013@3, and 03182013@14.

The recalled product

Product
SERMORELIN ACETATE 10 MG 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 — 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 (20)

  • 03182013@6
  • 03282013@26
  • 01142013@2
  • 01182013@2
  • 01172013@15
  • 02192013@3
  • 03062013@8
  • 04102013@3
  • 04262013@11
  • 05142013@35
  • 05212013@20
  • 5212013@17
  • 05242013@6
  • 06082013@3
  • 06072013@10
  • 06182013@27
  • 06292013@1
  • 07132013@2
  • 07232013@3
  • 03182013@14

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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