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Recall Observatory FDA recall evidence

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

June 09, 2017

Class II

Product summary

Firm
Advanced Pharma Inc.
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

    reason.potency_specification_failure · v1.0.0

    Stability Data Does Not Support Expiry