D-0878-2018 Class II Terminated
FDA drug recall D-0878-2018 was initiated by Dr. Reddy's Laboratories, Inc. on May 30, 2018 and is designated Class II. 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. The recall status is terminated (terminated Dec 14, 2020). Affected quantity: 6,397 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 27, 2018
- Initiation Date
- May 30, 2018
- Termination Date
- Dec 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,397 bottles
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
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: T800064, Exp 12/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0878-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026