FDA recall D-0116-2018

Product

NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.

Reason for recall

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

Distribution

Nationwide in the USA to hospitals and medical facilities.

Key facts

Status

Terminated

Initiation date

2017-06-09

Report date

2017-12-27

Termination date

2019-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0116-2018