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
Reported: April 17, 2019 Initiated: March 25, 2019 #D-1120-2019
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.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 2076 500-count Bottles
- Distribution
- Nationwide in the USA
- Location
- Mahwah, NJ
Frequently Asked Questions
What product 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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 2076 500-count Bottles.
Why was this product recalled? ▼
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 17, 2019. Severity: Moderate. Recall number: D-1120-2019.
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