FDAFDA · Food and drugs·Recall number D-0119-2018
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.
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
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
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: 4/20/17 0307 265-86361S, BUD 6/19/17; 4/26/17 0732 265-86361S, BUD 6/25/17; 4/28/17 0215 265-86361S, BUD 6/27/17; 5/2/17 0310 248-86361S, BUD 7/1/17; 5/4/17 1422 248-86361S, BUD 7/3/17; 5/12/17 0841 248-86361S, BUD 7/11/17; 5/18/17 0206 250-86361S, BUD 7/17/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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