Status
Terminated
Drug Enforcement D-0410-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Classification
Class II
Report Date
March 8, 2023
Termination Date
April 22, 2024
Product Information
- Product description
- Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-count bottle NDC 16729-005-17, UPC 3 16729 00517 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Product quantity
- 1,394,208 bottles
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- United States including Puerto Rico and Canada
Location & Firm
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Address
-
1009 Slater Rd Ste 210B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0410-2023
- Event ID
- 91657
- Recall initiation date
- February 7, 2023
- Center classification date
- March 2, 2023
- Code info
- Batches: a) P2102261, P2102284, P2102319, Exp. Date 3/31/2023, P2103536, Exp. Date 5/31/2023, P2104344, P2104342, P2104355, P2104356, P2104296, P2104380, Exp. Date 6/30/2023, R2200238, R2200239, Exp. Date 1/31/2024, R2200383, Exp. Date 2/28/2025; b) R2000554, R2000553, Exp. Date 9/30/2023; P2100562, P2100563,Exp. Date 12/31/2023; P2100692, P2100693, P2100722, P2100761, P2100762, P2101225, P2101200, P2101148, P2101149, P2101276, P2101345, Exp. Date 1/31/2024; P2101622, P2101664, P2101638, P2101785, P2101904, Exp. Date 2/29/2024; P2101951, P2101984, P2102367, P2102369, P2102368, P2102311, P2102316, P2102406, P2102455, Exp. Date 3/31/2024; P2102553, P2102554, P2102635, P2103233, P2103253, Exp. Date 4/30/2024; P2103360, P2103322, P2103414, P2103444, P2103415, P2103447, P2103573, P2103594, P2103615, P2103679, P2103648, P2103691, P2103646, P2103629, P2103704, P2103731, P2103763, P2103788, P2103789, P2103766, P2103876, P2103959, P2103833, Exp. Date 5/31/2024; P2103992; P2104045, P2104002, P2104046, P2104381, P2104407, P2104389, P2104644, P2104409, P2104649, P2104673, P2104684, P2104743, P2104696, P2104695, P2104745, P2105154, R2100826, R2100819, R2100829, P2104697, P2104746, P2105194, R2100837, R2100830, R2100836, P2105196, P2105220, P2105195, P2105222, R2100851, R2100856, Exp. Date 6/30/2024; P2105879, P2105920, P2105937, P2105973, P2105940, P2105986, P2105997, P2106009, P2106001, P2106010, P2106159, P2106182, P2106168, P2106202, P2106203, P2106217, P2106233, P2106214, P2106245, Exp. Date 8/31/2024; P2106333, P2106327, P2106342, P2106374, P2106405, P2106416, P2106429, P2106423, P2106412, Exp. Date 9/30/2024; R2200377, R2200542, R2200543, Exp. Date 2/28/2025; P2202795, P2202420, P2202445, Exp. Date 3/31/2025; R2200598, R2200590, R2200596, R2200591, P2202817, P2203290, P2202818, P2202819, Exp. Date 4/30/2025; P2203050, P2203006, P2203051, Exp. Date 5/31/2025;
- More code info
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