D-0692-2021 Class II
FDA drug recall D-0692-2021 was initiated by Innoveix Pharmaceuticals Inc on Jul 9, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility Affected quantity: 728 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 28, 2021
- Initiation Date
- Jul 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 728 vials
Product Description
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: SIP215 Exp. 01/14/2022, SIP220 Exp. 01/23/2022, SIP210 Exp. 12/15/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0692-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026