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Recall Observatory FDA recall evidence

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

June 09, 2017

Class II

Product summary

Firm
Advanced Pharma Inc.
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

    reason.potency_specification_failure · v1.0.0

    Stability Data Does Not Support Expiry