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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #C607323, Exp 10/18
Where it was sold
U.S. 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-0649-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 6, 2017
- FDA report date
- Apr 12, 2017
- Quantity
- 1,728 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0649-2017, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76699
- Address
- 107 College Rd E
- Code information
- Lot #C607323, Exp 10/18
- Postal code
- 08540-6623
- Report date
- Apr 12, 2017
- Product type
- Drugs
- Recall number
- D-0649-2017
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 1,728 bottles
- Termination date
- Dec 21, 2017
- Reason for recall
- Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S. nationwide
- Recall initiation date
- Mar 6, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2017