D-0300-2017 Class II Ongoing
FDA drug recall D-0300-2017 was initiated by Tri-Coast Pharmacy on November 17, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 7,168 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- January 11, 2017
- Initiation Date
- November 17, 2016
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,168 vials
Product Description
Testosterone Cypionate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide
Code Information
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05252016A (11/21/2016), 06272016B (12/24/2016), 07262016D (01/22/2017), 07182016H (01/14/2017), 07182016G (01/14/2017), 08252016C (02/21/2017), 08222016B (02/18/2017), 08102016A (02/06/2017), 09282016D (03/27/2017), 09222016E (03/21/2017), 09152016A (02/28/2017), 09062016B (02/28/2017), 10252016C (02/28/2017), 10042016E (04/02/2017).