Recalls / Class II
Class IID-0253-2015
Product
LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10
- Brand name
- Losartan Potassium
- Generic name
- Losartan Potassium
- Active ingredient
- Losartan Potassium
- Route
- Oral
- NDCs
- 42571-110, 42571-111, 42571-112
- FDA application
- ANDA091541
- Affected lot / code info
- Lot #LJAG003, Expiry: 05/2015
Why it was recalled
Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
Recalling firm
- Firm
- Micro Labs Usa, Inc S
- Manufacturer
- Micro Labs Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 104 Carnegie Ctr, Te 216, Princeton, New Jersey 08540-6232
Distribution
- Quantity
- 144 bottles
- Distribution pattern
- U.S. Including: New York
Timeline
- Recall initiated
- 2014-09-22
- FDA classified
- 2014-11-18
- Posted by FDA
- 2014-11-26
- Terminated
- 2015-12-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0253-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.