Home / Recalls / SterRx, LLC / D-0768-2021

D-0768-2021 Class II Terminated

Recalled by SterRx, LLC — Plattsburgh, NY

FDA drug recall D-0768-2021 was initiated by SterRx, LLC on August 10, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated May 19, 2022). Affected quantity: 3378 bags.

Recall Details

Product Type: Drugs
Report Date: September 1, 2021
Initiation Date: August 10, 2021
Termination Date: May 19, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3378 bags

Product Description

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the US

Code Information

Lot Numbers: BTW, exp. date 03/08/22 BUI, exp. date 03/16/22

Other recalls by SterRx, LLC

D-0931-2023 Class II — Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL S (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-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-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-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-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-0323-2022 Class II — PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride In (November 12, 2021)
D-0318-2022 Class II — MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per (November 12, 2021)
D-0311-2022 Class II — EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), (November 12, 2021)