The Recall Desk
SevereFDA (Drugs)·D-0142-2022·Announced 2021-11-17

Talon Compounding Pharmacy injectable lacks sterility assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable medication (QUAD-MIX) due to lack of assurance of sterility. The product 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 of a sterile injectable medication. Loss of sterility assurance in a parenteral (injection) product poses a significant risk of serious infection and other adverse health effects, justifying a Severe classification per the rubric for Class II recalls with inherent serious-injury risk.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling QUAD-MIX PAPAV 30/PHENTOL 4/PGE-1 40/ATROPINE 0.4 INJ *C6*, an injectable compounded medication, distributed across the United States, including Washington, D.C. and Puerto Rico. The product is available by prescription only and was manufactured by Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247.

The recall is issued because the pharmacy lacks assurance of sterility for this product. The affected lot is Lot 07192021:52, with a beyond-use date (BUD) of 11/30/2021.

Patients who have received this product should consult their healthcare provider immediately. Healthcare providers should not dispense this product and should consider notifying patients who may have received it. The FDA is overseeing this Class II recall.

The recalled product

Product
QUAD-MIX PAPAV 30/PHENTOL 4/PGE-1 40/ATROPINE 0.4 INJ *C6* 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-failure
  • microbial-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: 07192021:52 BUD: 11/30/2021

Distribution

Distribution scope not specified by the agency.

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