Home / Recalls / SterRx, LLC / D-0931-2023

D-0931-2023 Class II Terminated

Recalled by SterRx, LLC — Plattsburgh, NY

Recall Details

Product Type
Drugs
Report Date
July 26, 2023
Initiation Date
July 7, 2023
Termination Date
July 8, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
132,299 bags

Product Description

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.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 490062, Exp 22-Jul-23; 490151, Exp 28-Jul-23; 490732, Exp 6-Aug-23; 491591, Exp 17-Aug-23; 491604, Exp 18-Aug-23; 494418, Exp 16-Nov-23; 494426, Exp 17-Nov-23; 494434, Exp 23-Nov-23; 496755, Exp 25-Nov-23; 497424, Exp 3-Dec-23; 497432, Exp 4-Dec-23; 497441, 497459, Exp 7-Dec-23; 498005, Exp 10-Dec-23; 499075, Exp 22-Jan-24; 499083, 499091, Exp 25-Jan-24; 499391, Exp 26-Jan-24; 501964, Exp 23-Mar-24; 501972, Exp 28-Mar-24; 501981, Exp 30-Mar-24; 501999, Exp 6-Apr-24; 502001, Exp 7-Apr-24

Other recalls by SterRx, LLC

  • D-0933-2023 Class II — Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL (July 7, 2023)
  • D-0930-2023 Class II — Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per m (July 7, 2023)
  • D-0932-2023 Class II — Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL S (July 7, 2023)
  • D-0934-2023 Class II — Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL (July 7, 2023)
  • D-1331-2022 Class II — FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags (July 25, 2022)
  • D-1332-2022 Class II — fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV (July 25, 2022)
  • D-0325-2022 Class II — Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Pl (November 12, 2021)
  • D-0312-2022 Class II — Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx (November 12, 2021)
  • D-0306-2022 Class II — Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL (November 12, 2021)
  • D-0302-2022 Class II — dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, (November 12, 2021)