Advanced Pharma Recalls Subpotent Nitroglycerin Injection Syringes
Advanced Pharma Inc. is recalling Nitroglycerin injection syringes found to be subpotent, meaning they contain less active ingredient than labeled.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Advanced Pharma Inc. is recalling Nitroglycerin (2 mg/10 mL in 5% Dextrose Inj, USP) sterile single-dose syringes. The product is packaged in boxes of 25 syringes and is prescribed only. The recall involves Lot 4/19/17 1445 248-86361S with a beyond-use date of 6/18/2017.
The recall was initiated because the product was found to be subpotent, meaning it was below the specification for the labeled assay. This indicates the medication contains less active ingredient than stated on the label.
The affected syringes were distributed nationwide in the USA to hospitals and medical facilities. Healthcare facilities should stop using the recalled product and contact Advanced Pharma Inc. for further instructions.
The recalled product
- 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.
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable
- 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: 4/19/17 1445 248-86361S
- BUD¿6/18/2017
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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