FDA Recall D-0114-2018

Advanced Pharma Inc. · Houston, TX

Class I — life-threatening Terminated 663 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: 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

Quantity: 320 syringes

Reason for recall

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

Recall record

Recall number: D-0114-2018
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA to hospitals and medical facilities.
Recall initiated: 2017-06-09
Classified by FDA Center: 2017-12-20
FDA published: 2017-12-27
Terminated: 2019-04-03
Recalling firm: Advanced Pharma Inc.
Firm location: Houston, TX

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