FDA Drug recall D-0115-2018
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FI…
- FDA Drug
- Class I
- terminated
- Published 2017-12-27
On 2017-12-27 the FDA classified a Class I recall of NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FI… by Advanced Pharma, citing subpotent Drug: found to be below the specification for labeled assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0115-2018 |
| Classification | Class I |
| 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 (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 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 15082-863-61.
Reason
Subpotent Drug: found to be below the specification for labeled assay.
Identifiers
| code_info | Lot: 4/19/17 1445 248-86361S, BUD¿6/18/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class II · 2019-05-08 · Advanced Pharma - Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma - 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 9265…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma - Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe,…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma - Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe,…
FDA Drug · Class II · 2019-03-27 · Advanced Pharma
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0115-2018%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.