CLASS II Drug recall · Reported 26 Jul 2023 · FDA Enforcement Report
Norepinephrine 4 mg per (16 mcg per mL) recalled by SterRx
SterRx is recalling Norepinephrine 4 mg per (16 mcg per mL) in 0.9% Sodium Chloride Single Dose, distributed nationwide in the US. The recall was initiated on 7 Jul 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0931-2023
- FDA event ID
- 92657
- Recalling firm
- SterRx, Plattsburgh, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jul 2023
- FDA classified
- 19 Jul 2023
- Reported
- 26 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Allergy Medication
Timeline
| 7 Jul 2023 | Recall initiated by company | |
| 19 Jul 2023 | Classified by FDA | +12 days |
| 26 Jul 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 490062, Exp 22-Jul-23; 490151, Exp 28-Jul-23; 490732, Exp 6-Aug-23; 491591, Exp 17-Aug-23; 491604, Exp 18-Aug-23; 494418, Exp 16-Nov-23; 494426, Exp 17-Nov-23; 494434, Exp 23-Nov-23; 496755, Exp 25-Nov-23; 497424, Exp 3-Dec-23; 497432, Exp 4-Dec-23; 497441, 497459, Exp 7-Dec-23; 498005, Exp 10-Dec-23; 499075, Exp 22-Jan-24; 499083, 499091, Exp 25-Jan-24; 499391, Exp 26-Jan-24; 501964, Exp 23-Mar-24; 501972, Exp 28-Mar-24; 501981, Exp 30-Mar-24; 501999, Exp 6-Apr-24; 502001, Exp 7-Apr-24
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 92657| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq recalled by SterRx | SterRx | Sterility | Nationwide | |
| CLASS II | Norepinephrine 16 mg per (64 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide | |
| CLASS II | Norepinephrine 8 mg per (32 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide | |
| CLASS II | Norepinephrine 32 mg per (128 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
More recalls from SterRx
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Norepinephrine 32 mg per (128 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 8 mg per (32 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 16 mg per (64 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per (10 mcg per mL) IV recalled | SterRx | Sterility | Nationwide |
Other Norepinephrine Per ( Per Ml recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Norepinephrine 32 mg per (128 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 8 mg per (32 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 16 mg per (64 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 4 mg per (16 mcg per mL) in 5% Dextrose Injection recalled | SterRx | Sterility | Nationwide |