FDA Drug recall D-0149-2019
Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25
- FDA Drug
- Class III
- terminated
- Published 2018-11-07
On 2018-11-07 the FDA classified a Class III recall of Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25 by Pharm D Solutions, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0149-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-09-10 |
| Published | 2018-11-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pharm D Solutions |
| Distribution | US |
Product
Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebulization Solution 2.5% Inhal. Soln NDC 69699-0908-10; d) Nebulization 250 mL 2.5% Inhal Soln NDC 69699-0908-25; e) Oral Spray 2.5% 2.5% Oral Soln NDC 69699-0917-60, Pharm D Solutions, Houston, Texas
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lots: a) 05072018:40 Discard by: 5/2/2019; b) 07262018:44 Discard by: 1/22/2019; c) 07122018:83 Discard by: 7/12/2019;…Lots: a) 05072018:40 Discard by: 5/2/2019; b) 07262018:44 Discard by: 1/22/2019; c) 07122018:83 Discard by: 7/12/2019; d) 07262018:93 Discard by: 1/22/2019; e) 07262018:81 Discard by: 1/21/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0149-2019%22
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