FDA recall D-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

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

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-05-30

Report date

2018-06-27

Termination date

2020-12-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0878-2018