SterRx, LLC

FDA Regulatory Profile

SterRx, LLC has 35 FDA recalls (1 Class I), 3 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0930-2023 · Class II · Jul 7, 2023
Latest inspection
Jun 28, 2023 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls35 (1 Class I)Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0930-2023Class IISodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single…Jul 7, 2023
D-0933-2023Class IINorepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag…Jul 7, 2023
D-0934-2023Class IINorepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag…Jul 7, 2023
D-0931-2023Class IINorepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag…Jul 7, 2023
D-0932-2023Class IINorepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag…Jul 7, 2023
D-1331-2022Class IIFentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx…Jul 25, 2022
D-1332-2022Class IIfentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only…Jul 25, 2022
D-0301-2022Class IIMorphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only…Nov 12, 2021
D-0325-2022Class IISodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903…Nov 12, 2021
D-0313-2022Class IIMorphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141…Nov 12, 2021
D-0303-2022Class IINOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho…Nov 12, 2021
D-0300-2022Class IIMidazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141…Nov 12, 2021
D-0312-2022Class IIMidazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141…Nov 12, 2021
D-0306-2022Class IISodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx…Nov 12, 2021
D-0317-2022Class IIFentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only…Nov 12, 2021
D-0311-2022Class IIEPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx…Nov 12, 2021
D-0320-2022Class IINOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx…Nov 12, 2021
D-0302-2022Class IIdilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx…Nov 12, 2021
D-0315-2022Class IIdilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141…Nov 12, 2021
D-0309-2022Class IIEPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx…Nov 12, 2021

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 28, 2023Plattsburgh, NYDrugsOfficial Action Indicated (OAI)3010840309
Nov 4, 2021Plattsburgh, NYDrugsOfficial Action Indicated (OAI)3010840309
Mar 17, 2017Plattsburgh, NYDrugsVoluntary Action Indicated (VAI)3010840309

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3010840309Plattsburgh, NY3Jun 28, 2023

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.