FDA Drug recall D-0987-2017
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
- FDA Drug
- Class II
- terminated
- Published 2017-07-26
On 2017-07-26 the FDA classified a Class II recall of 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 by Pharmedium Services, citing lack of Assurance of Sterility; media fill failure at manufacturer.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0987-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-26 |
| Published | 2017-07-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmedium Services |
| Distribution | US |
Product
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
Reason
Lack of Assurance of Sterility; media fill failure at manufacturer
Identifiers
| code_info | Lots: a) 171320006S Exp. 8/13/2017, 171320014D Exp. 8/13/2017,171360020D Exp. 8/15/2017, 171520063D Exp. 8/31/2017; b)…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0987-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.