Drug 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.
D-0119-2018
Product summary
- Event
- Event 77503
- Status
- Terminated
- Classification
- Class II
- Quantity
- 550 syringes
- Official record key
drug-enforcement:D-0119-2018
Official wording
Reason: Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Code information: 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
Distribution pattern: Nationwide in the USA to hospitals and medical facilities.
Derived failure modes
-
Potency or specification failure
Stability Data Does Not Support Expiry