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fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Ch...

FDA Recall #D-0554-2020 — Class II — November 12, 2019

Recall #D-0554-2020 Date: November 12, 2019 Classification: Class II Status: Terminated

Product Description

fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1440-76

Reason for Recall

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

Recalling Firm

QuVa Pharma, Inc. — Sugar Land, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Distribution

Nationwide.

Code Information

Lots: 10029307 Exp. 11/14/2019, 10029939 Exp. 11/20/2019, 10029884 Exp. 11/19/2019, 10029915 Exp. 11/20/2019, 10030385 Exp. 11/25/2019, 10030386 Exp. 11/25/2019, 10030923 Exp. 12/11/2019, 10031320 Exp. 12/11/2019, 10031025 Exp. 12/12/2019, 10031024 Exp. 12/12/2019, 10032678 Exp. 1/8/2020, 10032993 Exp. 1/14/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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