PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: December 27, 2017 Initiated: June 9, 2017 #D-0117-2018

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Advanced Pharma Inc.
Units Affected
50 syringes
Distribution
Nationwide in the USA to hospitals and medical facilities.
Location
Houston, TX

Frequently Asked Questions

What product 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.. Recalled by Advanced Pharma Inc.. Units affected: 50 syringes.
Why was this product recalled?
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 27, 2017. Severity: Moderate. Recall number: D-0117-2018.