D-0263-2017 Class II Ongoing
FDA drug recall D-0263-2017 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: 5,229 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 11, 2017
- Initiation Date
- Nov 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,229 vials
Product Description
HCG 11,000 IU Vial. 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): 06152016A (12/12/2016), 07252016D (01/21/2017), 07112016C (01/07/2017), 08312016B (02/27/2017), 08262016B (02/22/2017), 08092016D (02/05/2017), 08052016A (02/01/2017), 09282016B (02/28/2017), 09222016D (02/28/2017), 09072016A (02/28/2017), 10252016J (02/28/2017), 10182016D (02/28/2017), 10102016H (02/28/2017), 11042016A (02/28/2017), 11012016E (02/28/2017)
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0263-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026