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Recall Observatory FDA recall evidence

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-0118-2018

June 09, 2017

Class II

Product summary

Firm
Advanced Pharma Inc.
Event
Event 77503
Status
Terminated
Classification
Class II
Quantity
680 syringes
Official record key
drug-enforcement:D-0118-2018

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: 4/26/17 0730 20-86367S, BUD 6/25/17; 4/24/17 0106 241-86367S, BUD 6/23/17; 5/1/17 1500 45-86367S, BUD 6/30/17; 5/9/17 1103 241-86367S, BUD 7/8/17; 5/9/17 1104 257-86367S, BUD 7/8/17; 5/12/17 0839 15-86367S, BUD 7/11/17; 5/19/17 0109 15-86367S, BUD 7/18/17; 5/22/17 0828 387-86367S, BUD 7/21/17; 5/23/17 0721 257-86367S, BUD 7/22/17; 5/24/17 0200 241-86367S, BUD 7/23/17; 5/24/17 0203 20-86367S, BUD 7/23/17; 5/26/17 0315 15-86367S, BUD 7/25/17; 5/31/17 1217 20-86367S, BUD 7/30/17

Distribution pattern: Nationwide in the USA to hospitals and medical facilities.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Stability Data Does Not Support Expiry