FDA recall D-1120-2019

Product

Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05

Reason for recall

Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-03-25

Report date

2019-04-17

Termination date

2020-09-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1120-2019