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FDANovember 12, 2019drug

fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

What to do

FDA enforcement status: Terminated

Brands named

quva pharmaquva

UPCs

70092110537

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37 — Recall Details · AllClear