CLASS I Drug recall · Reported 27 Dec 2017 · FDA Enforcement Report
NitroGlycerin 1 mg/ in 5% Dextrose Inj, USP QS recalled
Advanced Pharma is recalling NitroGlycerin 1 mg/ in 5% Dextrose Inj, USP QS (100 mcg per mL) Sterile single dose, distributed nationwide in the US. The recall was initiated on 9 Jun 2017 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0113-2018
- FDA event ID
- 77503
- Recalling firm
- Advanced Pharma, Houston, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 9 Jun 2017
- FDA classified
- 20 Dec 2017
- Reported
- 27 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 9 Jun 2017 | Recall initiated by company | |
| 20 Dec 2017 | Classified by FDA | +194 days |
| 27 Dec 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: found to be below the specification for labeled assay.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA to hospitals and medical facilities.
Questions about this recall
Why was it recalled?
Subpotent Drug: found to be below the specification for labeled assay.
Which lots are affected?
Lot: 4/17/17 0857 81861S, BUD 08/15/2017
Where was it sold?
Nationwide in the USA to hospitals and medical facilities.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 77503This product is part of a recall event; the main page for the event is NitroGlycerin (2 mg/ in 5% Dextrose Inj, USP QS recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | NitroGlycerin (2 mg/ in 5% Dextrose Inj, USP QS recalled | Advanced Pharma | Potency & Assay | Nationwide | |
| CLASS I | NitroGlycerin (1 mg/ 1 mg in 5% Dextrose Inj, USP QS recalled | Advanced Pharma | Potency & Assay | Nationwide | |
| CLASS II | NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj recalled by Advanced Pharma | Advanced Pharma | Potency & Assay | Nationwide | |
| CLASS II | NitroGlycerin 1 mg/ in 5% Dextrose Inj, USP QS recalled | Advanced Pharma | Potency & Assay | Nationwide | |
| CLASS I | NitroGlycerin (2 mg/ in 5% Dextrose Inj, USP QS recalled | Advanced Pharma | Potency & Assay | Nationwide | |
| CLASS II | NitroGlycerin (1 mg/ 1 mg in 5% Dextrose Inj, USP QS recalled | Advanced Pharma | Potency & Assay | Nationwide |
More recalls from Advanced Pharma
All 99| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | HYDROmorphone 20 mg/ Injectable Solution recalled by Advanced Pharma | Advanced Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Neostigmine Methylsulfate Injection Solution 5 mg recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Heparin in 0.45% Sodium Chloride, QS, Injectable Solution recalled | Advanced Pharma | Sterility | Nationwide |
Other Nitroglycerin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nitroglycerin injection, USP, 50 mg/ (5 mg/mL) recalledNitroglycerin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Nitroglycerin Sublingual Tablets 0.3MG recalledNitroglycerin | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nitroglycerin Sublingual Tablets 0.4MG recalledNitroglycerin | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays recalledNitroglycerin Lingual | Padagis US | Other | Nationwide |
| Drug | CLASS II | Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only recalledRectiv | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |