The Recall Desk

FDA (Drugs) recall action 82398

Advanced Pharma Inc. recalled 19 products on 2019-03-27

The FDA (Drugs) publishes a recall like this one as 19 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 19 pages.

Products
19
Announced
2019-03-27
Critical
0
Units
64,995

Why these products were recalled

Lack of Assurance of Sterility

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.

1–19 of 19

  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Glycopyrrolate Injectable Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 140 syringes of Glycopyrrolate 0.6 mg/3 mL Injectable Solution because the company cannot ensure the product is sterile.

    Product
    Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Phenylephrine HCl Injectable Solution Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,850 syringes of Phenylephrine HCl Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Fentanyl Injectable Solution Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 360 bags of fentanyl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Midazolam Injectable Solution Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,125 bags of Midazolam Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Hydromorphone Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 2,400 syringes of Hydromorphone HCl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 2,325 syringes of Morphine Sulfate 30 mg/30 mL Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe, NDC: 42852-241-63 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Phenylephrine HCl Injectable Syringes for Sterility Concerns

    Advanced Pharma Inc. is recalling 800 syringes of Phenylephrine HCl Injectable Solution due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Neostigmine Methylsulfate Injection Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 5,700 syringes of Neostigmine Methylsulfate Injection Solution because there is a lack of assurance of sterility.

    Product
    Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 2,580 syringes of Glycopyrrolate Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Esmolol HCl Injectable Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 550 syringes of Esmolol HCl Injectable Solution due to a lack of assurance of sterility. The affected products were distributed nationwide.

    Product
    Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Heparin Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,440 syringes of Heparin 5,000 Units/5mL Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe, NDC: 42852-739-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 22,900 syringes of Phenylephrine HCl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Phenylephrine Injectable Solution Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 975 units of Phenylephrine HCl injectable solution due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use syringe, NDC: 42852-882-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Heparin Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 500 syringes of Heparin 10 Units/10 mL due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Phenylephrine HCl Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 16,075 syringes of Phenylephrine HCl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC: 42852-830-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Lidocaine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,980 syringes of 2% Lidocaine HCl Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Fentanyl Injectable Solution Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 180 bags of fentanyl injectable solution nationwide due to a lack of assurance of sterility.

    Product
    fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,575 syringes of Phenylephrine HCl injectable solution because the company cannot guarantee the product is sterile.

    Product
    Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-03-27

    Advanced Pharma Recalls Lidocaine Syringes Due to Sterility Concerns

    Advanced Pharma Inc. is recalling 1,540 syringes of 2% Lidocaine HCl Injectable Solution because the company cannot assure the product's sterility.

    Product
    2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
    Category
    Distribution
    0 states