Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues
Advanced Pharma Inc. is recalling NitroGlycerin 1 mg/10 mL syringes because stability data does not support the expiry dates. The recall affects 4,800 syringes distributed nationwide to hospitals.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is related to stability data and container system support, which fits the criteria for a moderate severity recall involving potential quality issues without reported harm.
Plain-English summary
Advanced Pharma Inc. is recalling 4,800 syringes of NitroGlycerin 1 mg/10 mL in 5% Dextrose Injection, USP. The product is packaged in boxes of 25 syringes and is available by prescription only. The recall is being conducted because stability data does not support the use of the container system for the stated expiry dates.
The affected lots are identified as 3/3/17 1830 81861S with a best use date of 07/01/17, and 3/27/17 0658 81861S with a best use date of 7/25/17. The product was distributed nationwide in the USA to hospitals and medical facilities.
Hospitals and medical facilities should stop using the affected product and contact Advanced Pharma Inc. for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- 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.
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable
- Affected units
- 4,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: 3/3/17 1830 81861S
- BUD 07/01/17
- 3/27/17 0658 81861S
- BUD 7/25/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Advanced Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Advanced Pharma Inc.
See all →- HighAdvanced Pharma Recalls Sub-Potent Hydromorphone Injectable Solution
FDA (Drugs) · 2019-05-08
- SevereAdvanced Pharma Recalls Lidocaine Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- HighAdvanced Pharma Recalls Glycopyrrolate Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Heparin Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
- SevereAdvanced Pharma Recalls Phenylephrine HCl Injectable Solution Due to Sterility Concerns
FDA (Drugs) · 2019-03-27
Same hazard · stability data
See all →- ModerateOxytocin USP Powder Recalled Due to Insufficient Stability Data
FDA (Drugs) · 2018-03-21
- ModerateAmerican Pharmaceutical Ingredients Recalls Sermorelin Acetate Powder Due to Stability Data
FDA (Drugs) · 2018-03-21
- ModerateKalchem Recalls Vardenafil HCl Due to Missing Stability Data
FDA (Drugs) · 2018-03-14
- SevereApollo Care Recalls Vancomycin IV Bags Due to Stability Data Issues
FDA (Drugs) · 2018-03-14
- ModerateNandrolone Decanoate USP Recalled for Lack of Stability Data
FDA (Drugs) · 2018-02-28