US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 25, 2019 (7 years ago)

Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
Glenmark Pharmaceuticals Inc., USA
NDC code
68462-196-05
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1120-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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