Home / Recalls / Advanced Pharma Inc. / D-0115-2018

D-0115-2018 Class I Terminated

Recalled by Advanced Pharma Inc. — Houston, TX

Recall Details

Product Type
Drugs
Report Date
December 27, 2017
Initiation Date
June 9, 2017
Termination Date
April 3, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
50 syringes

Product Description

NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 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 15082-863-61.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA to hospitals and medical facilities.

Code Information

Lot: 4/19/17 1445 248-86361S, BUD¿6/18/2017

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  • D-1027-2019 Class II — 2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile si (March 13, 2019)
  • D-1016-2019 Class II — HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg (March 13, 2019)
  • D-1029-2019 Class II — Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single u (March 13, 2019)