FDAFDA · Food and drugs·Recall number D-0114-2018
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.
Published December 27, 2017 · Recall initiated: June 9, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: found to be below the specification for labeled assay.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Pharma Inc.
- Distributor
- Nationwide in the USA to hospitals and medical facilities.
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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