Recalls / Class II
Class IID-1325-2015
Product
Rivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60
- Brand name
- Rivastigmine Tartrate
- Generic name
- Rivastigmine Tartrate
- Active ingredient
- Rivastigmine Tartrate
- Route
- Oral
- NDCs
- 55111-352, 55111-353, 55111-354, 55111-355
- FDA application
- ANDA077130
- Affected lot / code info
- Lot #: C501342; Exp 01/2017
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 2,952 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-08-03
- FDA classified
- 2015-08-11
- Posted by FDA
- 2015-08-19
- Terminated
- 2017-03-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1325-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.