Drug recall
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC…
FDA recall event 77634 · Class II · PharMedium Services, Llc
Key facts
| Event ID | 77634 |
|---|---|
| Recall numbers | D-0985-2017, D-0986-2017, D-0987-2017, D-0988-2017, D-0989-2017, D-0990-2017, D-0991-2017, D-0992-2017, D-0993-2017, D-0994-2017, D-0995-2017, D-0996-2017 and 1 more |
| Recalling firm | PharMedium Services, Llc |
| Product type | Drugs |
| Products | Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11)…, 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#…, Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 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…, 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#…, Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 250 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service… and 8 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility; media fill failure at manufacturer |
| Initiation date | Jun 26, 2017 |
| Report date | Jul 26, 2017 |
| Termination date | Apr 29, 2020 |
| City | Sugar Land |
| State | TX |
| Country | United States |
| FEI number | 3000717703 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: