Drug recall D-0516-2023

Class II Ongoing reported Apr 12, 2023

Product

Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.

Reason for recall

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

Lots and codes

a) Lot: A1321V, D0221J, Exp. Date:8/31/2023; Lot: A1322J, Exp. Date: 5/31/2024; Lot: F0221Q, I0121E, I1021R, J1122D, Exp. Date: 10/31/2023; b) Lot: B0422J, Exp. Date: 5/31/2024; Lot: C1721K, Exp. Date: 8/31/2023; Lot: K1022Q, Exp. Date:11/30/2024.

Recall details

Recalling firm
Preferred Pharmaceuticals, Inc., Anaheim, CA
Quantity
a) 135 Bottles, b) 24 Bottles
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
March 23, 2023