D-0164-2019 Class II Terminated
FDA drug recall D-0164-2019 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: 442 vials.
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
- 442 vials
Product Description
HCG 6000 unit/0.3 gm Mannitol Lyopholized 6000 IU/vial injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1739-06
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
Lot: 04092018:14 Discard by: 10/6/2018; 06042018:54 Discard by: 12/1/2018; 05292018:81 Discard by: 11/25/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0164-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026