Why it was recalled
Labeling: Incorrect or Missing Package Insert
Product description
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01
Lot numbers, UPCs & expiration codes
Lot # FC1960; Exp.: 02/18
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-1036-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 25, 2016
- FDA report date
- Jun 22, 2016
- Quantity
- 3,048 bottles ( 304,800 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-1036-2016, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74326
- Address
- 100 College Rd W
- Code information
- Lot # FC1960; Exp.: 02/18
- Postal code
- 08540-6604
- Report date
- Jun 22, 2016
- Product type
- Drugs
- Recall number
- D-1036-2016
- Classification
- Class III
- Recalling firm
- Sandoz Inc
- Product quantity
- 3,048 bottles ( 304,800 tablets)
- Termination date
- Apr 25, 2017
- Reason for recall
- Labeling: Incorrect or Missing Package Insert
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01
- Distribution pattern
- Nationwide
- Recall initiation date
- May 25, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 16, 2016