Talon Compounding Pharmacy Quad-Mix Injectable Lacks Sterility Assurance
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, 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 medication with a critical sterility defect. Injectable products lacking sterility assurance carry significant risk of serious infection and warrant a Severe classification, even absent reported illnesses to date.
Plain-English summary
Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, is recalling Quad-Mix Papav 30/Phentol 3/PGE-1 100/Atropine 0.2 Injectable (Lot: 07162021:24, BUD: 11/13/2021) distributed nationwide including Washington D.C. and Puerto Rico due to lack of assurance of sterility.
The compounded injectable medication was distributed as a prescription-only product from the pharmacy's location at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247. The recall affects 2 vials of this product.
Patients who have received this medication should consult their healthcare provider immediately. The lack of sterility assurance in injectable medications poses a risk of serious infection. Consumers should not use this product and should return it to the pharmacy or healthcare provider who dispensed it.
The recalled product
- Product
- QUAD-MIX PAPAV 30/PHENTOL 3/PGE-1 100/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
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance
- infection-risk
- 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: 07162021:24 BUD: 11/13/2021
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27