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Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterR...

FDA Drug Recall #D-0306-2022 — Class II — November 12, 2021

Recall Summary

Recall Number D-0306-2022
Classification Class II — Moderate risk
Date Initiated November 12, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SterRx, LLC
Location Plattsburgh, NY
Product Type Drugs
Quantity 127,260 bags

Product Description

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Lot / Code Information

S20483/BNJ 23-Nov-21 S20484/BNK 24-Nov-21 S20485/BNL 25-Nov-21 S21008/BNV 3-Dec-21 S21010/BNX 9-Dec-21 S21025/BOM 10-Dec-21 S21026/BON 15-Dec-21 S21027/BOO 16-Dec-21 S21035/BOW 17-Dec-21 S21045/BPF 18-Dec-21 S21046/BPG 21-Dec-21 S21050/BPK 22-Dec-21 S21054/BPO 24-Dec-21 S21055/BPQ 25-Dec-21 S21061/BPW 28-Dec-21 S21062/BPX 29-Dec-21 S21063/BPY 30-Dec-21 S21064/BPZ 31-Dec-21 S21069/BQE 31-Dec-21 S21073/BQI 4-Jan-22 S21074/BQJ 5-Jan-22 S21076/BQL 6-Jan-22 S21077/BQM 7-Jan-22 S21081/BQQ 20-Jan-22 S21083/BQS 22-Jan-22 S21084/BQT 25-Jan-22 S21110/BRU 26-Jan-22 S21111/BRV 27-Jan-22 S21112/BRW 27-Jan-22 S21113/BRX 28-Jan-22 S21114/BRY 1-Feb-22 S21115/BRZ 1-Feb-22 S21123/BSH 2-Feb-22 S21124/BSI 3-Feb-22 S21126/BSK 3-Feb-22 S21127/BSL 4-Feb-22 S21128/BSM 4-Feb-22 S21129/BSN 5-Feb-22 S21168/BTZ 10-Mar-22 S21169/BUA 11-Mar-22 S21176/BUH 15-Mar-22 S21181/BUL 17-Mar-22 S21182/BUM 17-Mar-22 S21270/BXN 26-May-22 S21274/BXR 26-May-22 S21321/BZH 1-Jun-22 S21322/BZI 2-Jun-22 S21323/BZJ 3-Jun-22 S21324/BZK 3-Jun-22 S21325/BZL 7-Jun-22 S21329/BZP 8-Jun-22 S21336/BZW 14-Jun-22 S21337/BZX 15-Jun-22 S21338/BZY 16-Jun-22 S21341/CAB 17-Jun-22 S21343/CAD 18-Jun-22 S21348/CAH 23-Jun-22 S21350/CAJ 24-Jun-22 S21351/CAK 28-Jun-22 S21357/CAQ 1-Jul-22 S21360/CAT 2-Jul-22 S21363/CAW 5-Jul-22 S21366/CAZ 7-Jul-22 S21374/CBH 8-Jul-22 S21376/CBJ 8-Jul-22 S21377/CBK 12-Jul-22 S21381/CBO 13-Jul-22 S21384/CBR 13-Jul-22 S21387/CBU 13-Jul-22 S21390/CBX 14-Jul-22 S21392/CBZ 14-Jul-22 S21393/CCA 15-Jul-22 S21396/CCD 15-Jul-22 S21397/CCF 19-Jul-22 S21399/CCH 19-Jul-22 S21401/CCJ 20-Jul-22 S21404/CCM 21-Jul-22

Other Recalls from SterRx, LLC

Recall # Classification Product Date
D-0931-2023 Class II Norepinephrine 4 mg per 250 mL (16 mcg per mL) ... Jul 7, 2023
D-0932-2023 Class II Norepinephrine 8 mg per 250 mL (32 mcg per mL) ... Jul 7, 2023
D-0934-2023 Class II Norepinephrine 32 mg per 250 mL (128 mcg per mL... Jul 7, 2023
D-0930-2023 Class II Sodium Bicarbonate in 5% Dextrose Injection, 15... Jul 7, 2023
D-0933-2023 Class II Norepinephrine 16 mg per 250 mL (64 mcg per mL)... Jul 7, 2023

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.

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