Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
Reported: July 24, 2024 Initiated: June 28, 2024 #D-0612-2024
Product Description
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
Reason for Recall
Failed Dissolution Specifications: results below specifications
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- a) 145,800 bottles; b) 1,368 bottles
- Distribution
- USA Nationwide
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: a) 145,800 bottles; b) 1,368 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: results below specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 24, 2024. Severity: Moderate. Recall number: D-0612-2024.
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