US Drug Recall Register
Class II · Moderate risk Terminated Initiated Nov 12, 2019 (7 years ago)

fentaNYL 200 mcg/100 mL

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1255-75

Recalling firm
QuVa Pharma, Inc.
NDC code
70092-1255-75
Origin
TX, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0559-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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