D-1399-2019 Class II Terminated
FDA drug recall D-1399-2019 was initiated by Synthetopes Inc on May 28, 2019 and is designated Class II. Reason for recall: Lack of Processing Controls. The recall status is terminated (terminated October 15, 2020). Affected quantity: 20 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- June 19, 2019
- Initiation Date
- May 28, 2019
- Termination Date
- October 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 vials
Product Description
Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.
Reason for Recall
Lack of Processing Controls.
Distribution Pattern
Nationwide.
Code Information
All lots remaining within expiry.