Hydromorphone HCl 1 mg/mL in 0 recalled over sterility concerns

Recall date

November 18, 2016

Source

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

Official notice title

Cantrell Drug Company recalls Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV…

Recall number

D-0196-2017

FDA classification

Class II

Brand / firm

Cantrell Drug Company

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

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

What was recalled

Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), Single-Dose Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-006-10