CLASS III Drug recall · Reported 23 Mar 2016 · FDA Enforcement Report
NORepinephrine Bitartrate, 8 mg recalled by Pharmedium Services
Pharmedium Services is recalling NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection USP, distributed nationwide in the US. The recall was initiated on 31 Dec 2015 and the FDA has classified it as Class III.
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-0778-2016
- FDA event ID
- 72973
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 31 Dec 2015
- FDA classified
- 17 Mar 2016
- Reported
- 23 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 31 Dec 2015 | Recall initiated by company | |
| 17 Mar 2016 | Classified by FDA | +77 days |
| 23 Mar 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Which lots are affected?
Service Code 2K6127; 15342123S, exp 2/10/2016 15349071S, exp 2/17/2016 and 15351050S, exp 2/19/2016
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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
1 other product · FDA event 72973This product is part of a recall event; the main page for the event is NORepinephrine Bitartrate, 4 mg recalled by Pharmedium Services.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | NORepinephrine Bitartrate, 4 mg recalled by Pharmedium Services | Pharmedium Services | Potency & Assay | Nationwide |
More recalls from Pharmedium Services
All 291| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
Other Norepinephrine Bitartrate recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | norepinephrine Bitartrate,16mg per 0.9% Sodium Chloride recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | norepinephrine Bitartrate, 32mg per 0.9% Sodium Chloride recalled | Fagron Compounding Services | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg recalledNorepinephrine Bitartrate | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS III | Norepinephrine Bitartrate Injection, USP, 4 mg/* recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |