Drug 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.
D-0116-2018
Product summary
- Event
- Event 77503
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4800 syringes
- Official record key
drug-enforcement:D-0116-2018
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: 3/3/17 1830 81861S, BUD 07/01/17; 3/27/17 0658 81861S, BUD 7/25/17
Distribution pattern: Nationwide in the USA to hospitals and medical facilities.
Derived failure modes
-
Potency or specification failure
Stability Data Does Not Support Expiry