FDA Drug recall D-0976-2017
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceutica…
- FDA Drug
- Class II
- terminated
- Published 2017-07-19
On 2017-07-19 the FDA classified a Class II recall of Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceutica… by Sca Pharmaceuticals, citing lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0976-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-21 |
| Published | 2017-07-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sca Pharmaceuticals |
| Distribution | LA, NY, PA, WI |
Product
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40
Reason
Lack of sterility assurance
Identifiers
| code_info | Lot #: 20170509@2, Exp 6/23/2017; 20170524@22, Exp 7/8/2017; 20170602@10, Exp 7/17/2017; 20170609@27, Exp 7/24/2017 |
|---|
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-0976-2017%22
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