Advanced Pharma Inc. recalls NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5…

Recall date

June 9, 2017

Source

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

Recall number

D-0117-2018

FDA classification

Class II

Brand / firm

Advanced Pharma Inc.

Sold / distributed

Nationwide in the USA to hospitals and medical facilities.

Why it was recalled

Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.

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

What was recalled

NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.