Recalls / Class II
Class IID-0887-2022
Product
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 30 bottles/90 count = 2,700 tablets
- Distribution pattern
- Product was distributed to FL, SC and VA
Timeline
- Recall initiated
- 2022-05-02
- FDA classified
- 2022-05-20
- Posted by FDA
- 2022-06-01
- Terminated
- 2022-09-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0887-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.