Moderate riskFDA DrugClass II

Novadoz atorvastatin 40mg tablets recalled over foreign tablets

Novadoz Pharmaceuticals is recalling about 13,296 bottles of 1,000-count atorvastatin calcium 40mg tablets distributed nationwide. Some bottles may contain other tablets or capsules that are not atorvastatin. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check the bottle label for lot DRF09618A (exp. 08-31-2029) or DRG02110A (exp. 01-31-2030).
  2. Do not stop taking your prescription without talking to your doctor or pharmacist first.
  3. Contact your pharmacy or doctor for guidance on replacing affected tablets.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Atorvastatin Calcium Tablets, USP, 40mg, 1000 tablets per bottle, Rx only, Manufactured by: MSL Laboratories Private Limited, Telangana - 509228, India; Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854-3714. NDC: 72205-024-99
Sold in
Nationwide
Made for
Adults

Details

Units affected
13,296 1,000-count bottles
Illnesses reported
None reported
Manufactured in
Survey # 1277, 1319-1324, Nandigama (Village & Mandal), Rangareddy District, India
Classification
Class II
Recall number
D-0113-2027

In the FDA's words

Description
Atorvastatin Calcium Tablets, USP, 40mg, 1000 tablets per bottle, Rx only, Manufactured by: MSL Laboratories Private Limited, Telangana - 509228, India; Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854-3714. NDC: 72205-024-99 Presence of Foreign Tablets/Capsules Lot: DRF09618A, Exp 08-31-2029, DRG02110A, Exp 01-31-2030. Distribution: Nationwide in the USA. Affected quantity: 13,296 1,000-count bottles
Hazard
Presence of Foreign Tablets/Capsules

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