Status
Ongoing
Drug Enforcement D-0612-2024
Failed Dissolution Specifications: results below specifications
Classification
Class II
Report Date
July 24, 2024
Termination Date
—
Product Information
- 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,
- Product quantity
- a) 145,800 bottles; b) 1,368 bottles
- Reason for recall
- Failed Dissolution Specifications: results below specifications
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- USA Nationwide
Location & Firm
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Address
-
750 Corporate Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0612-2024
- Event ID
- 94899
- Recall initiation date
- June 28, 2024
- Center classification date
- July 18, 2024
- Code info
- Lot#: a) 17211249, 17211264, 17211266,17211286, Exp 6/30/24; 17211525, 17211535, 17211549, Exp 7/31/24; 17211787, 17211801, 8/31/24; 17212041, 9/30/24; 17212088, 17212106, Exp 10/31/24; 17212346, 17212345, 11/30/24; 17220053, 17220054, 17220055 12/31/24; 17220309, 17220310, Exp 1/31/25; b) 17211290, 6/30/2024
- More code info
- —