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Recall Observatory FDA recall evidence

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

June 09, 2017

Class II

Product summary

Firm
Advanced Pharma Inc.
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

    reason.potency_specification_failure · v1.0.0

    Stability Data Does Not Support Expiry