SterRx, LLC
SterRx, LLC appears in FDA public data with 35 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0934-2023, Class II) was initiated on July 7, 2023.
Summary
- Total Recalls
- 35 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0934-2023 | Class II | Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, pa | 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 Single Dose bag, pack | July 7, 2023 |
| D-0930-2023 | Class II | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single | 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 Single Dose bag, pac | 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 Single Dose bag, pack | 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, Rx only, SterRx, 1 | 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 bags, Rx Only, SterR | July 25, 2022 |
| D-0301-2022 | Class II | Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx | November 12, 2021 |
| D-0305-2022 | Class II | PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 I | November 12, 2021 |
| D-0313-2022 | Class II | Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Ida | November 12, 2021 |
| D-0300-2022 | Class II | Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Ida | November 12, 2021 |
| D-0302-2022 | Class II | dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 14 | November 12, 2021 |
| D-0312-2022 | Class II | Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 I | November 12, 2021 |
| D-0303-2022 | Class II | NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho | November 12, 2021 |
| D-0315-2022 | Class II | dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Ida | November 12, 2021 |
| D-0320-2022 | Class II | NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, | November 12, 2021 |
| D-0324-2022 | Class II | PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, Ste | November 12, 2021 |
| D-0309-2022 | Class II | EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 14 | November 12, 2021 |
| D-0316-2022 | Class II | Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, Ster | November 12, 2021 |
| D-0304-2022 | Class II | EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 | November 12, 2021 |