Drug recall D-0525-2023

Class II Ongoing reported Apr 12, 2023

Product

Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.

Reason for recall

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Lots and codes

a) Lot: B0922G, Exp. Date: 5/31/2023, F0322G, Exp. Date: 7/25/2024, H2622M, Exp. Date: 8/31/2024, J1422B, K0722G, Exp. Date: 10/31/2024, L1922A, Exp. Date: 2/28/2025; b) Lot: F2922S, Exp. Date: 8/31/2023, H0322G Exp. Date: 7/31/2023; c) Lot: A1322I, Exp. Date: 3/31/2023, H1122C, Exp. Date: 8/31/2024.

Recall details

Recalling firm
Preferred Pharmaceuticals, Inc., Anaheim, CA
Quantity
a) 88 Bottles, b) 3 Bottles, c) 175 Bottles
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
March 23, 2023