The Recall Desk
SevereFDA (Drugs)·D-0144-2022·Announced 2021-11-17

Sermorelin Acetate and Ipamorelin Injection Recall – Sterility Assurance

Talon Compounding Pharmacy is recalling Sermorelin Acetate 6mg/Ipamorelin 6mg lyophilized vials due to lack of assurance of sterility. The affected product was distributed across the United States, Washington, D.C., and Puerto Rico.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II drug recall involving lack of sterility assurance for an injectable product. Non-sterile injections present serious risk of infection and systemic complications. Although no specific illnesses or injuries are reported in the source, the Class II designation and the fundamental sterility defect in a parenteral pharmaceutical product meet the criteria for a Severe rating.

Plain-English summary

Talon Compounding Pharmacy (Vita Pharmacy, LLC) is recalling Sermorelin Acetate 6mg/Ipamorelin 6mg lyophilized vials, 6mg/6mg per vial, distributed as a prescription-only product from its facility in San Antonio, Texas. The recall is being conducted because the manufacturer cannot provide assurance of sterility for the affected lots.

The affected product consists of 11 vials total from three lots with the following codes: Lot 06022021:03 with Beyond Use Date (BUD) 11/29/2021; Lot 08102021:27 with BUD 11/30/2021; and Lot 05212021:84 with BUD 11/17/2021. Distribution of the recalled product extended throughout the United States, including Washington, D.C., and Puerto Rico.

Consumers or healthcare providers who have received this product should not use it. Patients currently using these vials should contact their healthcare provider or pharmacist immediately for guidance on obtaining a replacement product or alternative treatment.

The recalled product

Product
SERMORELIN ACETATE 6MG/IPAMORELIN 6MG - LYOPHILIZED 6MG/6MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Manufacturer
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Category
Drug — Injectable / Compounded Pharmacy
Hazard
  • sterility-assurance
  • infection-risk
  • injectable-contamination

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)

  • Lot: 06022021:03 BUD: 11/29/2021
  • 08102021:27 BUD: 11/30/2021
  • 05212021:84 BUD: 11/17/2021

Distribution

Distribution scope not specified by the agency.

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