Recall: D-1120-2019

Class II - Potentially Harmful

Class IIClassification

2019-03-25Initiated

TerminatedStatus

Glenmark Pharmaceuticals Inc.,Firm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.