RecallRadar

FDA Drug recall D-0022-2027

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…

On 2026-10-14 the FDA classified a Class II recall of Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific… by Carolina Infusion, citing lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0022-2027
ClassificationClass II
Statusongoing
Initiated2026-09-10
Published2026-10-14
Last updated2026-10-21 05:30 UTC
CompanyCarolina Infusion
DistributionUS

Product

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,

Reason

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

Identifiers

code_infoLot: 08072026@2, BUD:9/21/2026; 08032026@10, BUD:09/17/2026.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.

Other recalls by Carolina Infusion

All Carolina Infusion recalls

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0022-2027%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.