D-1120-2019 Class II Terminated
FDA drug recall D-1120-2019 was initiated by Glenmark Pharmaceuticals Inc., USA on March 25, 2019 and is designated Class II. Reason for recall: Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg. The recall status is terminated (terminated September 14, 2020). Affected quantity: 2076 500-count Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 17, 2019
- Initiation Date
- March 25, 2019
- Termination Date
- September 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2076 500-count Bottles
Product Description
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 for Recall
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 17181491 Exp. Aug. 2021