The Recall Desk
SevereFDA (Drugs)·D-0186-2022·Announced 2021-11-17

TRI-MIX PAPAVERINE Injectable Recalled Due to Sterility Assurance Failure

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.25/PGE-1 6 injectable vials due to lack of assurance of sterility. The injectable medication was 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 involving a sterile injectable product. Non-sterile injectable medications pose a direct risk of serious infection and potential hospitalization. The hazard of compromised sterility in injectable products meets the Severe criterion for Class II recalls with significant risk of harm.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.25/PGE-1 6 injectable vials (24 vials per unit) distributed across the United States, including Washington, D.C. and Puerto Rico. The recall was initiated due to lack of assurance of sterility.

Affected lots include: Lot 08192021:49 (BUD 02/08/2022), Lot 08102021:33 (BUD 11/30/2021), Lot 06302021:75 (BUD 10/23/2021), and Lot 09032021:05 (BUD 02/08/2022). This is a prescription-only injectable product manufactured by Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.

Patients who have received this medication should consult their healthcare provider immediately. Healthcare providers and patients with questions about this recall should contact the recalling firm or the FDA.

The recalled product

Product
TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.25/PGE-1 6 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 — Injectable / Compounded
Hazard
  • sterility-assurance-failure
  • 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 (4)

  • Lot:08192021:49 BUD: 02/08/2022
  • 08102021:33 BUD: 11/30/2021
  • 06302021:75 BUD: 10/23/2021
  • 09032021:05 BUD: 02/08/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

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