CLASS II Drug recall · Reported 26 Jul 2017 · FDA Enforcement Report
Potassium PHOSphate in 0.9% Sodium Chloride Injection recalled
PharMedium Services is recalling Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) in Intravia Bag, 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-0996-2017
- 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, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; media fill failure at manufacturer
Which lots are affected?
Lots: a) 171180027S Exp. 7/29/2017, 171220058D Exp. 8/1/2017, 171230013S Exp. 8/2/2017, 171360008S Exp. 8/14/2017, 171360019D Exp. 8/15/2017, 171380085D Exp. 8/17/2017, 171430069D Exp. 8/22/2017, 171560025D Exp. 9/4/2017; b) 171240007S Exp. 8/3/2017, 171280055D Exp. 8/7/2017, 171320003D Exp. 8/10/2017, 171320008S Exp. 8/13/2017, 171360005S Exp. 8/14/2017, 171370011S Exp. 8/16/2017, 171380086D Exp. 8/17/2017, 171500071D Exp. 8/29/2017
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 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
12 other products · FDA event 77634This product is part of a recall event; the main page for the event is Succinylcholine Chloride Injection (Preserved) 20 mg per mL recalled.
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 |
Other Potassium recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Potassium Acetate Injection, 2 mEq/mL recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS III | Potassium Acetate Injection, USP 40 mEq recalled | Exela Pharma Sciences | Packaging Defects | Nationwide |
| Drug | CLASS II | Potassium Phosphate, Monobasic, Crystal, NF recalled | Avantor Performance Materials | Potency & Assay | Nationwide |
| Drug | CLASS II | Potassium Citrate Extended-Release Tablets, USP, 15 mEq recalledPotassium Citrate | Vensun Pharmaceuticals | Other | PR |
| Drug | CLASS II | Potassium Citrate Extended-Release Tablets, USP, 10 mEq recalledPotassium Citrate | Vensun Pharmaceuticals | Other | PR |