The Recall Desk
HighFDA (Drugs)·D-0139-2022·Announced 2021-11-17

Talon Compounding Pharmacy Injectable Recalled for Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 200/ATROPINE 0.02 INJ due to lack of assurance of sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this recall as Class II. Lack of sterility assurance in an injectable drug is a risk-of-harm hazard that could result in serious infection or other complications. The source text does not report any illnesses or injuries, keeping the score at the maximum of 3 for a Class II recall with theoretical risk but no reported harm.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Lot 0802021:26 (BUD 11/30/2021) of QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 200/ATROPINE 0.02 INJ INJECTABLE (Rx only) due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.

Consumers who have received this product should not use it and should contact their healthcare provider immediately for further guidance. The product should be returned to Vita Pharmacy, LLC dba Talon Compounding Pharmacy or disposed of according to local regulations.

The recalled product

Product
QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 200/ATROPINE 0.02 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-assurance
  • 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: 0802021:26 BUD: 11/30/2021

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category