The Recall Desk

FDA (Drugs) recall action 77503

Advanced Pharma Inc. recalled 7 products on 2017-12-27

The FDA (Drugs) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2017-12-27
Critical
1
Units
7,000

Why these products were recalled

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

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • CriticalFDA (Drugs)··2017-12-27

    Advanced Pharma Recalls Subpotent Nitroglycerin Injection Syringes

    Advanced Pharma Inc. is recalling Nitroglycerin injection syringes found to be subpotent, meaning they contain less active ingredient than labeled.

    Product
    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.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-12-27

    Advanced Pharma Recalls Subpotent NitroGlycerin Injection Syringes Nationwide

    Advanced Pharma Inc. is recalling 550 syringes of NitroGlycerin injection found to be subpotent. The product was distributed nationwide to hospitals and medical facilities.

    Product
    NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 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 15082-818-61.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-12-27

    Advanced Pharma Recalls Subpotent Nitroglycerin Injection Syringes

    Advanced Pharma Inc. is recalling 320 syringes of Nitroglycerin injection that were found to be subpotent, meaning they contain less active ingredient than labeled.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling 680 syringes of NitroGlycerin injection because stability data does not support the product's expiry dates.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling NitroGlycerin 1 mg/10 mL syringes because stability data does not support the expiry dates. The recall affects 4,800 syringes distributed nationwide to hospitals.

    Product
    NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 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 15082-818-61.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling NitroGlycerin 100 mcg/mL syringes because stability data does not support the product's expiry date.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2017-12-27

    Advanced Pharma Recalls NitroGlycerin Syringes Due to Stability Data Issues

    Advanced Pharma Inc. is recalling NitroGlycerin injection syringes because stability data does not support the product's expiry date.

    Product
    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.
    Category
    Distribution
    0 states