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 15 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-0987-2017
- 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 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11; d) 250 mL in 250 mL Intravia Bag with Additive Cap Service Code 2K5291 NDC# 61553-291-11, 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) 171320006S Exp. 8/13/2017, 171320014D Exp. 8/13/2017,171360020D Exp. 8/15/2017, 171520063D Exp. 8/31/2017; b) 171280054D Exp. 8/7/2017, 171320002D Exp. 8/10/2017, 171370005S Exp. 8/15/2017, 171440016D Exp. 8/23/2017, 171450012D Exp. 8/24/2017, 171510059D Exp. 8/30/2017, 171560027D Exp. 9/4/2017; c) 171170014S Exp. 7/27/2017, 171210127S Exp. 7/31/2017, 171230071D Exp. 8/2/2017, 171240002D Exp. 8/3/2017, 171240004D Exp. 8/3/2017, 171240191S Exp. 8/3/2017, 171280041D Exp. 8/7/2017, 171290077D Exp. 8/8/2017, 171300076D Exp. 8/9/2017, 171310058D Exp. 8/10/2017, 171320059D Exp. 8/13/2017, 171320190S Exp. 8/13/2017, 171360062D Exp. 8/15/2017, 171360068D Exp. 8/15/2017, 171380076D Exp. 8/17/2017, 171390064D Exp. 8/20/2017, 171390065D Exp. 8/20/2017, 171500064D Exp. 8/29/2017, 171530101S Exp. 9/3/2017, 171570058D Exp. 9/5/2017; d) 171210005S Exp. 7/30/2017, 171230008D Exp. 8/2/2017, 171500072D Exp. 8/29/2017, 171560028D Exp. 9/4/2017
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.
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|---|---|---|---|---|---|
| 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 |