Status
Ongoing
Drug Enforcement D-0512-2023
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
- Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703
- Product quantity
- a) 375 Bottles b) 323 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-0512-2023
- Event ID
- 91952
- Recall initiation date
- March 23, 2023
- Center classification date
- April 6, 2023
- Code info
- a) Lot: B1522B, Exp 4/30/2023; lot:C0222H, C0322B, Exp 5/31/2023; lot: E1022H, F13220, H2222P, Exp 6/30/2023; Lot: I1422V, K01220, Exp 12/31/2023; Lot: L2722H, Exp 3/31/2024; b) Lot:C0322B, Exp 5/31/2023; lot:H1122G, 12322Q, Exp 6/30/2023; lot: J1222U, Exp 12/31/2023.
- More code info
- —