Recalls / Class III
Class IIID-1036-2016
Product
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01
- Affected lot / code info
- Lot # FC1960; Exp.: 02/18
Why it was recalled
Labeling: Incorrect or Missing Package Insert
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 3,048 bottles ( 304,800 tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-05-25
- FDA classified
- 2016-06-16
- Posted by FDA
- 2016-06-22
- Terminated
- 2017-04-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1036-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.