Drug product
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.
D-0114-2018
Product summary
- Event
- Event 77503
- Status
- Terminated
- Classification
- Class I
- Quantity
- 320 syringes
- Official record key
drug-enforcement:D-0114-2018
Official wording
Reason: Subpotent Drug: found to be below the specification for labeled assay.
Code information: 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
Distribution pattern: Nationwide in the USA to hospitals and medical facilities.
Derived failure modes
-
Potency or specification failure
Subpotent