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FDANovember 12, 2019drug

fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37

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

70092120737

Recall history

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

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fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37 — Recall Details · AllClear