D-0521-2023 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 12, 2023
- Initiation Date
- March 23, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 Bottles
Product Description
Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9
Reason for Recall
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Distribution Pattern
USA Nationwide
Code Information
Lot: F1021I; H3122J, Exp 4/30/2024