Why it was recalled
Lack of Assurance of Sterility
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0306-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 12, 2021
- FDA report date
- Jan 5, 2022
- Quantity
- 127,260 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SterRx, LLC
Original FDA data
Every field from FDA enforcement report D-0306-2022, exactly as published.
Show all FDA fields
- City
- Plattsburgh
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89059
- Address
- 141 Idaho Ave
- 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
- Postal code
- 12903-3987
- Report date
- Jan 5, 2022
- Product type
- Drugs
- Recall number
- D-0306-2022
- Classification
- Class II
- Recalling firm
- SterRx, LLC
- Product quantity
- 127,260 bags
- Termination date
- Dec 6, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Nov 12, 2021
- Initial firm notification
- Press Release
- Center classification date
- Dec 29, 2021