D-0299-2017 Class II Ongoing
FDA drug recall D-0299-2017 was initiated by Tri-Coast Pharmacy on Nov 17, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 2,818 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 11, 2017
- Initiation Date
- Nov 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,818 vials
Product Description
Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 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): 05232016D (11/19/2016), 06162016A (12/13/2016), 06132016A (12/10/2016), 07282016I (01/24/2017), 08172016D (02/13/2017), 08042016C (01/31/2017), 09222016F (03/21/2017), 09062016A (02/28/2017), 10272016B (02/28/2017), 10252016D (02/28/2017), 08252016B (02/21/2017), 11022016C (05/01/2017).
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0299-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026