Why it was recalled
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Product description
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
Lot numbers, UPCs & expiration codes
T60045
Where it was sold
U.S.A. 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-1079-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 2, 2018
- FDA report date
- Aug 22, 2018
- Quantity
- 2280 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1079-2018, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80675
- Address
- 107 College Rd E
- Code information
- T60045
- Postal code
- 08540-6623
- Report date
- Aug 22, 2018
- Product type
- Drugs
- Recall number
- D-1079-2018
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 2280 bottles
- Termination date
- Apr 15, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Aug 2, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 14, 2018