D-0149-2019 Class III Terminated

Recalled by Pharm D Solutions, LLC — Houston, TX

FDA drug recall D-0149-2019 was initiated by Pharm D Solutions, LLC on Sep 10, 2018 and is designated Class III. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Feb 5, 2021). Affected quantity: 57 bottles; 2300 milliliters.

Recall Details

Product Type
Drugs
Report Date
Nov 7, 2018
Initiation Date
Sep 10, 2018
Termination Date
Feb 5, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
57 bottles; 2300 milliliters

Product Description

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 for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

Code Information

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

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0149-2019
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.