Potassium PHOSphate in 0 — Class II drug recall D-0987-2017
Terminated recall by PharMedium Services, Llc, reported 2017-07-26, distributed nationwide. Lack of Assurance of Sterility; media fill failure at manufacturer
| Recall number | D-0987-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PharMedium Services, Llc, Sugar Land, TX, United States |
| Recall initiated | 2017-06-26 |
| Classified | 2017-07-14 |
| Reported by FDA | 2017-07-26 |
| Terminated | 2020-04-29 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 61553-0282-11, 61553-0291-11, 61553-0292-01, 61553-0295-48 |
| Expiration dates | 2017-07-27, 2017-07-30, 2017-07-31, 2017-08-02, 2017-08-03, 2017-08-07, 2017-08-08, 2017-08-09, 2017-08-10, 2017-08-13, 2017-08-15, 2017-08-17, 2017-08-20, 2017-08-23, 2017-08-24, 2017-08-29, 2017-08-30, 2017-08-31, 2017-09-03, 2017-09-04, 2017-09-05 |
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 for recall
Lack of Assurance of Sterility; media fill failure at manufacturer
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0987-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.