The Recall Desk
SevereFDA (Drugs)·D-0218-2022·Announced 2021-11-17

Compounded TRI-MIX Injectable Recalled for Lack of Sterility Assurance

Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ injectable medication due to lack of assurance of sterility. The recall affects vials distributed across the United States, including 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 of a compounded injectable pharmaceutical product with lack of sterility assurance, which presents a serious risk of infection if non-sterile product is administered. Non-sterile injectables pose significant hazard of serious illness and hospitalization, meeting the Severe criteria.

Plain-English summary

Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas, is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ, an injectable prescription medication supplied in 2 vials. The recall was initiated due to lack of assurance of sterility.

The affected product has the following lot numbers and Beyond Use Dates (BUD): Lot 05142021:17 with BUD 10/23/2021, and Lot 08062021:79 with BUD 02/02/2022. The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.

Patients who have received this product should consult their healthcare provider immediately. Healthcare providers should advise patients not to use remaining product and direct them to seek medical evaluation if symptoms develop.

The recalled product

Product
TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 40 INJ INJECTABLE, 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 Injectable
Hazard
  • sterility-failure
  • compounding-error
  • infection-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 (2)

  • Lot: 05142021:17 BUD: 10/23/2021
  • 08062021:79 BUD: 02/02/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category