Why it was recalled
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Product description
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.
Lot numbers, UPCs & expiration codes
Lot # C905063, Exp 07/2021
Where it was sold
Distributed 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-0599-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 4, 2021
- FDA report date
- Jun 2, 2021
- Quantity
- 2980 500 count -bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0599-2021, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87879
- Address
- 107 College Rd E
- Code information
- Lot # C905063, Exp 07/2021
- Postal code
- 08540-6623
- Report date
- Jun 2, 2021
- Product type
- Drugs
- Recall number
- D-0599-2021
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 2980 500 count -bottles
- Termination date
- Feb 16, 2023
- Reason for recall
- Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- May 4, 2021
- Initial firm notification
- Letter
- Center classification date
- May 27, 2021