CLASS III Drug recall · Reported 1 Jan 2020 · FDA Enforcement Report
NORepinephrine Bitartrate 8 mg added to 5% Dextrose recalled
Pharmedium Services is recalling NORepinephrine Bitartrate 8 mg added to 5% Dextrose Injection USP (16 mcg per mL) Total, distributed nationwide in the US. The recall was initiated on 16 Dec 2019 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-0626-2020
- FDA event ID
- 84525
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Dec 2019
- FDA classified
- 23 Dec 2019
- Reported
- 1 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 16 Dec 2019 | Recall initiated by company | |
| 23 Dec 2019 | Classified by FDA | +7 days |
| 1 Jan 2020 | Published in enforcement report | +9 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
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 added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #s: 193040035S, Exp. 12/29/2019; 193120031S, Exp. 01/08/2020; 193150024S, Exp. 01/09/20; 193180030S, Exp. 01/12/20; 193240028S, Exp. 01/18/20; 193250022S, Exp. 01/19/20.
Where was it sold?
Nationwide in the U.S.
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
2 other products · FDA event 84525| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | NORepinephrine Bitartrate 8 mg added to 5% Dextrose recalled | Pharmedium Services | Potency & Assay | Nationwide | |
| CLASS III | NORepinephrine Bitartrate 4 mg added to 5% Dextrose recalled | 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 |