D-0885-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 1, 2022
- Initiation Date
- May 4, 2022
- Termination Date
- September 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 bottles/90 count each
Product Description
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Distribution Pattern
Recalled product was distributed to Florida.
Code Information
Lot # B1377711-100521, exp. date 10/31/2022 B1412137-102621, exp. date 10/31/2022