FDAClass IIDecember 27, 2017

NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj recall

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.

Why was NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj recalled?

Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 5/31/17 0202 5-81862S, BUD 7/30/17

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.
Recalling firm
Advanced Pharma Inc.
Quantity
50 syringes
Distribution
Nationwide in the USA to hospitals and medical facilities.
Recall date
December 27, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls