FDAClass IDecember 27, 2017

NitroGlycerin recall: Subpotent

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.

Why was NitroGlycerin recalled?

Subpotent Drug: found to be below the specification for labeled assay.

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: 4/10/17 1441 257-86367S, BUD 6/9/17; 4/17/17 0950 86367S, BUD¿6/16/2017; 4/20/17 1505 257-86367S, BUD 6/19/2017; 4/24/17 0115 15-86367S, BUD ¿6/23/2017; 4/26/17 0301 387-86367S, BUD 6/25/2017

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