The Recall Desk
SevereFDA (Drugs)·D-0109-2022·Announced 2021-11-17

CJC-1295/Ipamorelin Injections Recalled Due to Sterility Concerns

Talon Compounding Pharmacy is recalling CJC-1295 and Ipamorelin injectable vials distributed across the United States because the manufacturer cannot assure sterility of the products.

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: The FDA classified this as a Class II recall. Lack of sterility assurance for injectable pharmaceutical products presents a serious risk of infection or other adverse health consequences to patients who receive non-sterile injections.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling CJC-1295 4MG/Ipamorelin 4MG injectable vials. The recall affects 15 vials distributed throughout the United States, including Washington, D.C. and Puerto Rico.

The recall was issued because the manufacturer cannot provide assurance that the products meet sterility standards. Affected lot numbers include 05242021:73 (BUD: 08/22/2021), 08032021:26 (BUD: 11/01/2021), 06022021:49 (BUD: 08/31/2021), and 08122021:97 (BUD: 11/10/2021).

Consumers or healthcare providers who have received these products should discontinue use and consult with their healthcare provider regarding the recall.

The recalled product

Product
CJC-1295 4MG/IPAMORELIN 4MG VIAL 4MG/4MG INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Manufacturer
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Hazard
  • sterility-assurance-failure
  • injectable-contamination-risk

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 (4)

  • Lot: 05242021:73 BUD: 08/22/2021
  • 08032021:26 BUD: 11/01/2021
  • 06022021:49 BUD: 08/31/2021
  • 08122021:97 BUD: 11/10/2021

Distribution

Distribution scope not specified by the agency.