The Recall Desk

FDA (Drugs) recall action 92657

SterRx, LLC recalled 5 products on 2023-07-26

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2023-07-26
Critical
0
Units
489,437

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.

1–5 of 5

  • HighFDA (Drugs)··2023-07-26

    Norepinephrine Injectable Recalled Due to Lack of Sterility Assurance

    SterRx recalled 2,088 bags of Norepinephrine 32 mg per 250 mL (Lot #490100) distributed nationwide due to lack of sterility assurance. The recall affects a critical care medication used in intensive care settings.

    Product
    Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-07-26

    Norepinephrine injectable medication recalled nationwide for sterility assurance

    SterRx recalled 125,598 bags of norepinephrine injectable medication nationwide because the manufacturer could not guarantee the product's sterility. The recalled medication has expiration dates from July 2023 to April 2024.

    Product
    Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-07-26

    Norepinephrine injectable recalled due to sterility assurance concerns

    SterRx is recalling norepinephrine injections due to lack of assurance of sterility. The recall affects 132,299 bags distributed nationwide.

    Product
    Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-07-26

    Sodium Bicarbonate Injectable Solution Recalled for Sterility Assurance Issues

    SterRx is recalling 137,304 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide because the manufacturer cannot assure the product meets sterility standards. Affected lots have expiration dates from July 2023 through February 2024.

    Product
    Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-07-26

    Norepinephrine injectable recalled due to lack of sterility assurance

    SterRx is recalling 92,148 bags of norepinephrine injectable due to lack of assurance of sterility. The prescription medication was distributed nationwide.

    Product
    Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.
    Category
    Distribution
    0 states