D-0250-2017 Class II Ongoing
FDA drug recall D-0250-2017 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: 67 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
- 67 vials
Product Description
B-Complex (30 ML), (Thiamine HCL 100 mg/Riboflavin-5-Phosphate 2 mg/Pyridoxine HCL 2 mg/Niacinamide 100 mg/Methylcobalamin 300 mcg/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): 07262016E (12/31/2016), 10262016E (02/28/2017).