Recalls / Class II
Class IID-0885-2022
Product
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
- Affected lot / code info
- Lot # B1377711-100521, exp. date 10/31/2022 B1412137-102621, exp. date 10/31/2022
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
- 22 bottles/90 count each
- Distribution pattern
- Recalled product was distributed to Florida.
Timeline
- Recall initiated
- 2022-05-04
- 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-0885-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.