Recalls / Class II
Class IID-0892-2022
Product
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
- Affected lot / code info
- Lot: K1721E, EXP: 4/30/2023, NDC: 68788-7758-03; Lot: H3021Q, EXP: 2/28/2023, NDC: 68788-7758-03.
Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, Anaheim, California 92807-1801
Distribution
- Quantity
- 47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q).
- Distribution pattern
- Within the U.S in FL and CA.
Timeline
- Recall initiated
- 2022-05-03
- FDA classified
- 2022-05-24
- Posted by FDA
- 2022-06-01
- Terminated
- 2022-09-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0892-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.