The Recall Desk
SevereFDA (Drugs)·D-0143-2022·Announced 2021-11-17

Sermorelin Acetate/Ipamorelin Vials Recalled for Lack of Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Sermorelin Acetate 15MG/Ipamorelin 15MG lyophilized vials due to lack of assurance of sterility. The affected lot 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 recall. Lack of assurance of sterility in an injectable compounded pharmaceutical presents a significant risk of serious infection and potential hospitalization. The agency's classification alone warrants a minimum score of 4 per the rubric.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247, is recalling Sermorelin Acetate 15MG/Ipamorelin 15MG lyophilized vials (15MG/15MG per vial, prescription-only) due to lack of assurance of sterility. This is an FDA Class II recall.

The affected product is lot 07062021:98 with a beyond-use date (BUD) of 11/30/2021, distributed in packages of 6 vials across the United States, including Washington, D.C. and Puerto Rico.

Patients and healthcare providers who have received this product should stop use and contact their healthcare provider or pharmacist for guidance on alternative treatments or replacement product. Persons who believe they have experienced an adverse reaction should contact the FDA's MedWatch program or local poison control center.

The recalled product

Product
SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG 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 — Compounded Pharmaceutical
Hazard
  • sterility-failure
  • 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 (1)

  • Lot: 07062021:98 BUD: 11/30/2021

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category