Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90
Lot numbers, UPCs & expiration codes
Lot #: T600327, Exp 07/18; T700213, T700215, Exp 04/19
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-0886-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 12, 2018
- FDA report date
- Jun 27, 2018
- Quantity
- 55,126 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0886-2018, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80275
- Address
- 107 College Rd E
- Code information
- Lot #: T600327, Exp 07/18; T700213, T700215, Exp 04/19
- Postal code
- 08540-6623
- Report date
- Jun 27, 2018
- Product type
- Drugs
- Recall number
- D-0886-2018
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 55,126 bottles
- Termination date
- Nov 8, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Jun 12, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 21, 2018