CLASS I Drug recall · Reported 2 Sep 2015 · FDA Enforcement Report
EPINEPHrine HCl 4 mg added to 9% Sodium Chloride Injection recalled
Pharmedium Services is recalling EPINEPHrine HCl 4 mg added to 9% Sodium Chloride Injection USP (16 mcg per mL), distributed nationwide in the US. The recall was initiated on 13 Apr 2015 and the FDA has classified it as Class I.
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-1358-2015
- FDA event ID
- 71846
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 13 Apr 2015
- FDA classified
- 25 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Particulate Matter
- Drug class
- Allergy Medication
Timeline
| 13 Apr 2015 | Recall initiated by company | |
| 25 Aug 2015 | Classified by FDA | +134 days |
| 2 Sep 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Product as listed by the FDA
EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6119, NDC# 61553-119-61.
Where it was distributed
Nationwide
Questions about this recall
Is EPINEPHrine HCl 4 mg added to 9% Sodium Chloride Injection USP (16 mcg per mL) recalled?
Yes. Pharmedium Services recalled EPINEPHrine HCl 4 mg added to 9% Sodium Chloride Injection USP (16 mcg per mL) on 13 Apr 2015. The recall is Class I and its status is Terminated. Recall number D-1358-2015.
Why was it recalled?
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Which lots are affected?
Lot #: 15033030S, 15033031S, Exp 04/26/15; 15026051S, Exp 05/03/15
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 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 |