Home / Recalls / SterRx, LLC / D-0305-2022

D-0305-2022 Class II Terminated

Recalled by SterRx, LLC — Plattsburgh, NY

FDA drug recall D-0305-2022 was initiated by SterRx, LLC on November 12, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated December 6, 2023). Affected quantity: 18,948 bags.

Recall Details

Product Type: Drugs
Report Date: January 5, 2022
Initiation Date: November 12, 2021
Termination Date: December 6, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 18,948 bags

Product Description

PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

S21086/BQW 14-Dec-21 S21149/BTH 23-Jan-22 S21159/BTQ 30-Jan-22 S21265/BXI 3-Apr-22 S21305/BYU 24-Apr-22 S21311/BZA 26-Apr-22

Other recalls by SterRx, LLC

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-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-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-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-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-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-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-0321-2022 Class II — NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injecti (November 12, 2021)
D-0301-2022 Class II — Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per (November 12, 2021)