Avella of Deer Valley, Inc. Store 38 product recalled over sterility concerns

Recall date

June 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Avella of Deer Valley, Inc. Store 38 recalls 0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cass…

Recall number

D-0942-2018

FDA classification

Class II

Brand / firm

Avella of Deer Valley, Inc. Store 38

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: Potential leakage of bags.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87