CLASS III Drug recall · Reported 21 Jun 2017 · FDA Enforcement Report
Potassium PHOSphate added to 9% Sodium Chloride, 5 mMol, Service recalled
Pharmedium Services is recalling Potassium PHOSphate added to 9% Sodium Chloride, 5 mMol, Service, distributed nationwide in the US. The recall was initiated on 17 Feb 2017 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-0909-2017
- FDA event ID
- 77191
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Feb 2017
- FDA classified
- 12 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Feb 2017 | Recall initiated by company | |
| 12 Jun 2017 | Classified by FDA | +115 days |
| 21 Jun 2017 | 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
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Product as listed by the FDA
Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Potassium PHOSphate added to 9% Sodium Chloride, 5 mMol, Service recalled?
Yes. Pharmedium Services recalled Potassium PHOSphate added to 9% Sodium Chloride, 5 mMol, Service on 17 Feb 2017. The recall is Class III and its status is Terminated. Recall number D-0909-2017.
Why was it recalled?
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Which lots are affected?
Lot Numbers: 163640146S, 3/30/2017; 170020187S, 4/3/2017; 170100120S, 4/11/2017; 170200117S, 4/23/2017; 170340009S, 5/6/2017
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 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 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.
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