CLASS II Drug recall · Reported 26 Jul 2017 · FDA Enforcement Report
Potassium PHOSphate in 9% Sodium Chloride Injection recalled
PharMedium Services is recalling Potassium PHOSphate in 9% Sodium Chloride Injection, 7 mMol in in Intravia, distributed nationwide in the US. The recall was initiated on 26 Jun 2017 and the FDA has classified it as Class II.
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-0991-2017
- FDA event ID
- 77634
- Recalling firm
- PharMedium Services, Sugar Land, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jun 2017
- FDA classified
- 14 Jul 2017
- Reported
- 26 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Jun 2017 | Recall initiated by company | |
| 14 Jul 2017 | Classified by FDA | +18 days |
| 26 Jul 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; media fill failure at manufacturer
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48
Where it was distributed
Nationwide
Questions about this recall
Is Potassium PHOSphate in 9% Sodium Chloride Injection, 7 mMol in in Intravia recalled?
Yes. PharMedium Services recalled Potassium PHOSphate in 9% Sodium Chloride Injection, 7 mMol in in Intravia on 26 Jun 2017. The recall is Class II and its status is Terminated. Recall number D-0991-2017.
Why was it recalled?
Lack of Assurance of Sterility; media fill failure at manufacturer
Which lots are affected?
Lots: 171220061D Exp. 8/1/2017, 171250023D Exp. 8/6/2017, 171430008D Exp. 8/22/2017, 171450015D Exp. 8/24/2017, 171510062D Exp. 8/30/2017
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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|---|---|---|---|---|---|
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