D-1406-2019 Class II Terminated
FDA drug recall D-1406-2019 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: 45 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
- 45 vials
Product Description
Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Reason for Recall
Lack of Processing Controls.
Distribution Pattern
Nationwide.
Code Information
All lots remaining within expiry.