Why it was recalled
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Product description
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
Lot numbers, UPCs & expiration codes
C500202
Where it was sold
US 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-0468-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 13, 2016
- FDA report date
- Feb 15, 2017
- Quantity
- 5,904 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0468-2017, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75442
- Address
- 107 College Rd E
- Code information
- C500202
- Postal code
- 08540-6623
- Report date
- Feb 15, 2017
- Product type
- Drugs
- Recall number
- D-0468-2017
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 5,904 bottles
- Termination date
- Jul 24, 2017
- Reason for recall
- Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
- Distribution pattern
- US Nationwide
- Recall initiation date
- Oct 13, 2016
- Initial firm notification
- Letter
- Center classification date
- Feb 3, 2017