D-0159-2019 Class II Terminated
FDA drug recall D-0159-2019 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: 1171 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
- 1171 vials
Product Description
HCG 10,000 unit/0.3 gm Mannitol Lyopholized, Pharm D Solutions, Houston, Texas ---- NDC 69699-1711-10
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
Lot: 04182018:46 Discard by: 10/14/2018; 06072018:65 Discard by: 12/3/2018; 05082018:01 Discard by: 11/4/2018; 07282018:20 Discard by: 1/24/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0159-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026