Recalls / Class II
Class IID-393-2014
Product
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
- Affected lot / code info
- Lot CU0856
Why it was recalled
Subpotent; Hydrochlorothiazide at the 9 month time point.
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4700 Sandoz Dr, Wilson, North Carolina 27893-8143
Distribution
- Quantity
- 2,491 bottles of 100 tablets each
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-10-11
- FDA classified
- 2013-12-30
- Posted by FDA
- 2014-01-08
- Terminated
- 2015-03-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-393-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.