NitroGlycerin (Advanced Pharma) – Stability Concerns (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Advanced Pharma Inc.
Lot Codes / Batch Numbers
Lot: 3/3/17 1830 81861S, BUD 07/01/17, 3/27/17 0658 81861S, BUD 7/25/17
Products Sold
Lot: 3/3/17 1830 81861S, BUD 07/01/17; 3/27/17 0658 81861S, BUD 7/25/17
Advanced Pharma Inc. is recalling NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose due to Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026