FDA-Drug2019-04-17Class II
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
Glenmark Pharmaceuticals Inc., USA
Hazard
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Sold states
Nationwide in the USA
Affected count
2076 500-count Bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1120-2019Don't want to check this manually?
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