D-0887-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 1, 2022
- Initiation Date
- May 2, 2022
- Termination Date
- September 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 bottles/90 count = 2,700 tablets
Product Description
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Distribution Pattern
Product was distributed to FL, SC and VA
Code Information
Lot # B1364261-092721, exp. date 09/30/2022 B1377667-100521, exp. date 10/31/2022 B1412576-102621, exp. date 10/31/2022 B1436925-111321, exp. date 11/30/2022