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 (32 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-0625-2020
- 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 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 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: 192930039S Exp. 12/18/19; 192930041S Exp. 12/18/19; 192940048S Exp. 12/19/19; 192940049S Exp. 12/19/19; 192950031S Exp. 12/20/19; 192950032S Exp. 12/20/19; 192960039S Exp. 12/22/19; 192960040S Exp. 12/22/19; 192960041S Exp. 12/22/19; 192960042S Exp. 12/22/19; 192970034S Exp. 12/22/19; 192970036S Exp. 12/22/19; 192970037S Exp. 12/22/19; 192980043S Exp. 12/25/19; 192980044S Exp. 12/25/19; 192980045S Exp. 12/25/19; 193010042S Exp. 12/26/19; 193020042S Exp. 12/27/19; 193030039S Exp. 12/28/19; 193030040S Exp. 12/28/19; 193030049S Exp. 12/28/19; 193040045S Exp. 12/29/19; 193040046S Exp. 12/29/19; 193040047S Exp. 12/29/19; 193080040S Exp. 1/2/20; 193080041S Exp. 1/2/20; 193080042S Exp. 1/2/20; 193080043S Exp. 1/2/20; 193080044S Exp. 1/2/20; 193090034S Exp. 1/3/20; 193090035S Exp. 1/3/20; 193090036S Exp. 1/3/20; 193100041S Exp. 1/4/20; 193100042S Exp. 1/4/20; 193100043S Exp. 1/4/20; 193120036S Exp. 1/8/20; 193150028S Exp. 1/9/20; 193170033S Exp. 1/11/20; 193170034S Exp. 1/11/20; 193170035S Exp. 1/11/20; 193180035S Exp. 1/12/20; 193190035S Exp. 1/15/20; 193190038S Exp. 1/15/20; 193220038S Exp. 1/16/20; 193230037S Exp. 1/17/20; 193240029S Exp. 1/18/20; 193240030S Exp. 1/18/20; 193240031S Exp. 1/18/20; 193250028S Exp. 1/19/20; 193360031S Exp. 1/30/20
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 84525This product is part of a recall event; the main page for the event is NORepinephrine Bitartrate 8 mg added to 5% Dextrose recalled.
| 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 |
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|---|---|---|---|---|---|
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| Drug | CLASS II | rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |