Reported Jul 24, 2024 · Ongoing
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC…
Glenmark Pharmaceuticals Inc., USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
Pravastatin Sodium TabletsUSP 80mgpackaged in a) 90-count bottleNDC 68462-198-90b) 500-count bottleNDC 68462-198-05Rx only
- Manufactured byGlenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India
- Manufactured forGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430
- Lot codes and dates
Lot#: a) 17211249172112641721126617211286Exp 6/30/24172115251721153517211549Exp 7/31/2417211787172118018/31/24172120419/30/241721208817212106Exp 10/31/24172123461721234511/30/24172200531722005417220055 12/31/241722030917220310Exp 1/31/25b) 172112906/30/2024
- Amount recalled
- a) 145,800 bottles; b) 1,368 bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: results below specifications
This product could cause temporary or reversible health problems — stop using it.
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