Status
Terminated
Drug Enforcement D-0561-2023
CGMP deviations.
Classification
Class II
Report Date
May 10, 2023
Termination Date
April 30, 2024
Product Information
- Product description
- Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
- Product quantity
- 393 bottles
- Reason for recall
- CGMP deviations.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US.
Location & Firm
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Address
-
727 N Ann Arbor Ave
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0561-2023
- Event ID
- 92081
- Recall initiation date
- April 6, 2023
- Center classification date
- May 1, 2023
- Code info
- Lots: a) A22A17, D22C21 Exp. 07/31/23; K22D89, L22B26, L22D14 Exp. 03/31/24; L22D96 Exp. 04/30/24; b) L21E06 Exp. 05/31/23; B22C05, D22B91, E22C82 Exp. 07/31/23; G22B03 G22B79, H22A30, J22B81 Exp. 08/31/23; J22F27, K22B37, K22B88 Exp. 10/31/23; L22D32 Exp. 03/31/24; B23E07 Exp. 04/30/24
- More code info
- —