Why it was recalled
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Product description
Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900
Lot numbers, UPCs & expiration codes
Lot #: T800064, Exp 12/2019
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-0878-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 30, 2018
- FDA report date
- Jun 27, 2018
- Quantity
- 6,397 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0878-2018, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80208
- Address
- 107 College Rd E
- Code information
- Lot #: T800064, Exp 12/2019
- Postal code
- 08540-6623
- Report date
- Jun 27, 2018
- Product type
- Drugs
- Recall number
- D-0878-2018
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 6,397 bottles
- Termination date
- Dec 14, 2020
- Reason for recall
- Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 30, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 18, 2018