D-0301-2017 Class II Ongoing
FDA drug recall D-0301-2017 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: 1,544 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 11, 2017
- Initiation Date
- Nov 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,544 vials
Product Description
Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 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): 07262016A (01/22/2017), 07132016C (01/09/2017), 08302016A (02/26/2017), 08042016D (01/31/2017), 11012016K (04/30/2017), 09202016D (03/19/2017), 10032016B (04/01/2017), 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).
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0301-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026