The Recall Desk
SevereFDA (Drugs)·D-0135-2022·Announced 2021-11-17

Talon Compounding Pharmacy Injectable Drug Lacks Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling QUAD-MIX PAPAV 20/PHENTOL 2/PGE-1 25/ATROPINE 0.2 INJ due to lack of assurance of sterility. The recall affects one lot 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: The FDA classified this as a Class II recall. Lack of sterility assurance in injectable medications is a serious hazard that can result in infection, sepsis, and other serious adverse health outcomes, warranting a Severe severity rating.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling QUAD-MIX PAPAV 20/PHENTOL 2/PGE-1 25/ATROPINE 0.2 INJ, an injectable prescription medication, due to lack of assurance of sterility.

The affected product is Lot 08032021:56 with a Beyond Use Date of 11/30/2021. The product was distributed throughout the United States, including Washington D.C. and Puerto Rico.

Consumers who have received this medication should consult their healthcare provider or pharmacist immediately. The medication should not be used and should be returned to Talon Compounding Pharmacy or disposed of according to local pharmaceutical waste disposal guidelines.

The recalled product

Product
QUAD-MIX PAPAV 20/PHENTOL 2/PGE-1 25/ATROPINE 0.2 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
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: 08032021:56 BUD: 11/30/2021

Distribution

Distribution scope not specified by the agency.