Why it was recalled
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Product description
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05
Lot numbers, UPCs & expiration codes
Lot numbers: a) T600126, 3/2018; T600202 and T600247 5/2018, b) T600126, 3/2018; T600202, and T600247, 5/2018
Where it was sold
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-0419-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 29, 2018
- FDA report date
- Feb 7, 2018
- Quantity
- a) 28,941 and b) 2,928 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0419-2018, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79065
- Address
- 107 College Rd E
- Code information
- Lot numbers: a) T600126, 3/2018; T600202 and T600247 5/2018, b) T600126, 3/2018; T600202, and T600247, 5/2018
- Postal code
- 08540-6623
- Report date
- Feb 7, 2018
- Product type
- Drugs
- Recall number
- D-0419-2018
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- a) 28,941 and b) 2,928 bottles
- Termination date
- Dec 7, 2018
- Reason for recall
- Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 29, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 13, 2018