Advanced Pharma Inc. recalls NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, pack…

Recall date

June 9, 2017

Source

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

Recall number

D-0118-2018

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 (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.