Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Product description
Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
Lot numbers, UPCs & expiration codes
Lot #: a) JKP3150B, Exp 06/17, JKR5749A, Exp 06/18; b) JKP2757A, Exp 05/17, JKP3149A, JKP3150A, Exp 06/17, JKR5049A, Exp 04/18; c) JKP2758B, Exp 05/17
Where it was sold
Nationwide in the USA and Puerto Rico
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-0700-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 22, 2017
- FDA report date
- May 17, 2017
- Quantity
- 6,138 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0700-2017, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76819
- Address
- 270 Prospect Plains Rd
- Code information
- Lot #: a) JKP3150B, Exp 06/17, JKR5749A, Exp 06/18; b) JKP2757A, Exp 05/17, JKP3149A, JKP3150A, Exp 06/17, JKR5049A, Exp 04/18; c) JKP2758B, Exp 05/17
- Postal code
- 08512-3605
- Report date
- May 17, 2017
- Product type
- Drugs
- Recall number
- D-0700-2017
- Classification
- Class III
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 6,138 bottles
- Termination date
- Jul 11, 2018
- Reason for recall
- Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Mar 22, 2017
- Initial firm notification
- Letter
- Center classification date
- May 10, 2017