FDA Drug recall D-0116-2018
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 FIV…
- FDA Drug
- Class II
- terminated
- Published 2017-12-27
On 2017-12-27 the FDA classified a Class II recall of 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 FIV… by Advanced Pharma, citing stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0116-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-09 |
| Published | 2017-12-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Advanced Pharma |
| Distribution | US |
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
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Identifiers
| code_info | Lot: 3/3/17 1830 81861S, BUD 07/01/17; 3/27/17 0658 81861S, BUD 7/25/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0116-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.