Recalls / Class III
Class IIID-0649-2017
Product
RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 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 #C607323, Exp 10/18
Why it was recalled
Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
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
- 1,728 bottles
- Distribution pattern
- U.S. nationwide
Timeline
- Recall initiated
- 2017-03-06
- FDA classified
- 2017-04-06
- Posted by FDA
- 2017-04-12
- Terminated
- 2017-12-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0649-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.