Status
Terminated
Drug Enforcement D-0560-2023
CGMP deviations.
Classification
Class II
Report Date
May 10, 2023
Termination Date
April 30, 2024
Product Information
- Product description
- Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)
- Product quantity
- 520 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-0560-2023
- Event ID
- 92081
- Recall initiation date
- April 6, 2023
- Center classification date
- May 1, 2023
- Code info
- Lots: a) G22B32, D22B92, D22F82, Exp. 06/30/23; G22F41, J22F25, L22C14, Exp. 01/31/24; D22B92, D22F82 Exp. 06/30/23; B22A12, Exp. 03/31/23 b) H22A32, I22E83, J22E94, K22E34 Exp. 01/31/24; C22F31, D22G16, E22D75, F22E06, Exp. 06/30/23; L21E09, B22C61, Exp. 01/31/23.
- More code info
- —