Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Product description
Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.
Lot numbers, UPCs & expiration codes
Lot #: a) C700220, Exp 06/18; b) C700220, Exp 06/18
Where it was sold
Nationwide in the USA
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-1038-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 11, 2017
- FDA report date
- Aug 9, 2017
- Quantity
- 544 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1038-2017, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 77734
- Address
- 107 College Rd E
- Code information
- Lot #: a) C700220, Exp 06/18; b) C700220, Exp 06/18
- Postal code
- 08540-6623
- Report date
- Aug 9, 2017
- Product type
- Drugs
- Recall number
- D-1038-2017
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 544 bottles
- Termination date
- Apr 1, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 11, 2017
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2017