Recalls / Class II
Class IID-0878-2018
Product
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
- Brand name
- Atorvastatin Calcium
- Generic name
- Atorvastatin Calcium
- Active ingredient
- Atorvastatin Calcium Trihydrate
- Route
- Oral
- NDC
- 55111-124
- FDA application
- ANDA202357
- Affected lot / code info
- Lot #: T800064, Exp 12/2019
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.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 6,397 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-05-30
- FDA classified
- 2018-06-18
- Posted by FDA
- 2018-06-27
- Terminated
- 2020-12-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0878-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.