Advanced Pharma Recalls Subpotent Nitroglycerin Injection Syringes
Advanced Pharma Inc. is recalling 320 syringes of Nitroglycerin injection that were 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 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 per the rubric mandates a minimum severity score of 4 (Severe).
Plain-English summary
Advanced Pharma Inc. is recalling 320 syringes of NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL. The product is packaged in boxes of 40 syringes and is available by prescription only. The recall involves specific lots with expiration dates ranging from June 2017 to June 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 that the medication may not contain the full amount of active ingredient stated on the 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/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 320
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 (10)
- Lot: 4/10/17 1441 257-86367S
- BUD 6/9/17
- 4/17/17 0950 86367S
- BUD¿6/16/2017
- 4/20/17 1505 257-86367S
- BUD 6/19/2017
- 4/24/17 0115 15-86367S
- BUD ¿6/23/2017
- 4/26/17 0301 387-86367S
- BUD 6/25/2017
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.
See all 7 products in this recall →Related recalls
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