The Recall Desk
HighFDA (Drugs)·D-0902-2022·Announced 2022-06-01

Sermorelin Acetate Injection Recalled Due to Sterility Assurance Failure

Olympia Compounding Pharmacy is recalling Sermorelin Acetate injectable powder because of insufficient assurance of sterility. Patients using affected lots should contact their healthcare provider.

What this means for you

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: This is an FDA Class II recall with no reported illnesses or injuries. Per the severity rubric, it qualifies as a risk-of-harm product (injectable medication with sterility assurance failure) where injury has not yet been reported, which corresponds to a score of 3 (High).

Plain-English summary

Olympia Compounding Pharmacy, located in Orlando, Florida, is recalling Sermorelin Acetate Lyophilized powder for injection (9 mg per vial) because the product cannot be assured to meet sterility requirements. A total of 4,459 vials have been recalled.

The affected lots are: L24115 (BUD 12/15/2022), A24203 (BUD 01/03/2023), and A24106 (BUD 01/06/2023). These vials were distributed nationwide in the United States, Puerto Rico, and the U.S. Virgin Islands.

Sermorelin Acetate is a prescription injectable medication. Patients who have used this product should contact their healthcare provider immediately, particularly if they have vials matching the recalled lot numbers.

Healthcare providers should check their supplies for the recalled lot numbers and cease dispensing any affected vials. Patients with concerns about their treatment should speak with their healthcare provider about alternative options.

The recalled product

Product
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
  • sterility-assurance-failure

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 (3)

  • Lots: L24115 BUD: 12/15/2022
  • A24203 BUD: 01/03/2023
  • A24106 BUD: 01/06/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category