Status
Ongoing
Drug Enforcement D-0519-2023
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Classification
Class II
Report Date
April 12, 2023
Termination Date
—
Product Information
- Product description
- Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
- Product quantity
- a) 59 Bottles, b) 77 Bottles
- Reason for recall
- cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA Nationwide
Location & Firm
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Address
-
1250 N Lakeview Ave Ste O
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0519-2023
- Event ID
- 91952
- Recall initiation date
- March 23, 2023
- Center classification date
- April 6, 2023
- Code info
- a) Lot: F2022N, Exp. Date: 2/29/2024; b) Lot: F0322I, Exp. Date: 8/31/2023; Lot: J1322H, Exp. Date: 2/29/2024; Lot: K0222N, Exp. Date: 6/30/2024; Lot: L2322D and Lot: L2822J, Exp. Date:7/31/2025.
- More code info
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