Drug product
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.
D-0117-2018
Product summary
- Event
- Event 77503
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 syringes
- Official record key
drug-enforcement:D-0117-2018
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: 5/31/17 0202 5-81862S, BUD 7/30/17
Distribution pattern: Nationwide in the USA to hospitals and medical facilities.
Derived failure modes
-
Potency or specification failure
Stability Data Does Not Support Expiry