Recalls / Class II
Class IID-1500-2014
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90
- Brand name
- Losartan Potassium And Hydrochlorothiazide
- Generic name
- Losartan Potassium And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Losartan Potassium
- Route
- Oral
- NDCs
- 59746-337, 59746-338, 59746-339
- FDA application
- ANDA201845
- Affected lot / code info
- Lot #14P0292, Exp 04/2016
Why it was recalled
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 9,358 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-07-11
- FDA classified
- 2014-07-31
- Posted by FDA
- 2014-08-06
- Terminated
- 2016-09-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1500-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.