Why it was recalled
Subpotent; Hydrochlorothiazide at the 9 month time point.
Product description
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
Lot numbers, UPCs & expiration codes
Lot CU0856
Where it was sold
Nationwide
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-393-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 11, 2013
- FDA report date
- Jan 8, 2014
- Quantity
- 2,491 bottles of 100 tablets each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-393-2014, exactly as published.
Show all FDA fields
- City
- Wilson
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 66554
- Address
- 4700 Sandoz Dr
- Code information
- Lot CU0856
- Postal code
- 27893-8143
- Report date
- Jan 8, 2014
- Product type
- Drugs
- Recall number
- D-393-2014
- Classification
- Class II
- Recalling firm
- Sandoz Inc
- Product quantity
- 2,491 bottles of 100 tablets each
- Termination date
- Mar 5, 2015
- Reason for recall
- Subpotent; Hydrochlorothiazide at the 9 month time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 11, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 30, 2013