Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues
Advanced Pharma Inc. is recalling NitroGlycerin 100 mcg/mL syringes because stability data does not support the product's expiry date.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Advanced Pharma Inc. is recalling NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringes. The recall is being conducted because stability data does not support the use of the container system for the stated expiry date.
The affected product is packaged in boxes of 50 syringes and is distributed nationwide in the USA to hospitals and medical facilities. The specific lot number is 5/31/17 0202 5-81862S, with a best-use date of 7/30/17.
Hospitals and medical facilities should stop using the affected product and contact Advanced Pharma Inc. for further instructions. Consumers should not use this prescription medication if they have it in their possession.
The recalled product
- Product
- NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 50
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 (2)
- Lot: 5/31/17 0202 5-81862S
- BUD 7/30/17
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.
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