Advanced Pharma Recalls Subpotent NitroGlycerin Injection Syringes Nationwide
Advanced Pharma Inc. is recalling 550 syringes of NitroGlycerin injection found to be subpotent. The product was distributed nationwide to hospitals and medical facilities.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric.
Plain-English summary
Advanced Pharma Inc. is recalling 550 syringes of NitroGlycerin 1 mg/10 mL in 5% Dextrose Injection, USP. The product is packaged in boxes of 25 syringes and is identified by NDC 15082-818-61. The specific lot affected is 4/17/17 0857 81861S, with a beyond-use date of 08/15/2017.
The recall was initiated because the drug was found to be subpotent, meaning it was below the specification for labeled assay. This indicates the medication may not contain the full amount of the active ingredient required by its label.
The affected product was 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 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 — Injection
- Hazard
- Affected units
- 550
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: 4/17/17 0857 81861S
- BUD 08/15/2017
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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