Why it was recalled
Failed Dissolution Specifications
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: C501342; Exp 01/2017
Where it was sold
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-1325-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 3, 2015
- FDA report date
- Aug 19, 2015
- Quantity
- 2,952 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1325-2015, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71906
- Address
- 107 College Rd E
- Code information
- Lot #: C501342; Exp 01/2017
- Postal code
- 08540-6623
- Report date
- Aug 19, 2015
- Product type
- Drugs
- Recall number
- D-1325-2015
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 2,952 bottles
- Termination date
- Mar 24, 2017
- Reason for recall
- Failed Dissolution Specifications
- 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, India, NDC 55111-352-60
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 3, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 11, 2015