CLASS II 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 II.
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-0116-2018
- FDA event ID
- 77503
- Recalling firm
- Advanced Pharma, Houston, TX
- Classification
- Class II
- 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
- Sterility
- 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
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
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
Is NitroGlycerin 1 mg/ in 5% Dextrose Inj, USP QS (100 mcg per mL) Sterile single dose recalled?
Yes. Advanced Pharma recalled NitroGlycerin 1 mg/ in 5% Dextrose Inj, USP QS (100 mcg per mL) Sterile single dose on 9 Jun 2017. The recall is Class II and its status is Terminated. Recall number D-0116-2018.
Why was it recalled?
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Which lots are affected?
Lot: 3/3/17 1830 81861S, BUD 07/01/17; 3/27/17 0658 81861S, BUD 7/25/17
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 | Sterility | Nationwide |
| Drug | CLASS II | Neostigmine Methylsulfate Injection Solution 5 mg recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCl, 1,200 mcg in 9% Sodium Chloride recalled | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 1 mg in 9% Sodium Chloride recalled by Advanced Pharma | Advanced Pharma | Sterility | Nationwide |
| Drug | CLASS II | Heparin in 45% Sodium Chloride, QS, Injectable Solution recalled | Advanced Pharma | Sterility | Nationwide |