Why it was recalled
Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #14P0292, Exp 04/2016
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1500-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 11, 2014
- FDA report date
- Aug 6, 2014
- Quantity
- 9,358 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1500-2014, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 68776
- Address
- 207 Kiley Dr
- Code information
- Lot #14P0292, Exp 04/2016
- Postal code
- 21801-2249
- Report date
- Aug 6, 2014
- Product type
- Drugs
- Recall number
- D-1500-2014
- Classification
- Class II
- Recalling firm
- Jubilant Cadista Pharmaceuticals Inc.
- Product quantity
- 9,358 bottles
- Termination date
- Sep 15, 2016
- Reason for recall
- Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 11, 2014
- Initial firm notification
- Telephone
- Center classification date
- Jul 31, 2014