D-0168-2019 Class II Terminated
FDA drug recall D-0168-2019 was initiated by Pharm D Solutions, LLC on Sep 10, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Feb 5, 2021). Affected quantity: 24500 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
- 24500 milliliters
Product Description
Methylcobalamin 1 mg/mL a) 10 mL Injectable NDC 69699-1501-10; b) 30 mL Injectable NDC 69699-1501-30, Pharm D Solutions, Houston, Texas
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
Lot: a) 04242018:27 Discard by: 9/15/2018; 04302018:55 Discard by: 10/27/2018; b) 03192018:33 Discard by: 9/15/2018; 05222018:28 Discard by: 11/18/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0168-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026