Drug recall D-0518-2023

Class II Ongoing reported Apr 12, 2023

Product

Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), 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: F3021D, Exp 12/31/2023, Lot: L0722T, Exp 5/31/2025; b) Lot: F1021I, Exp 12/31/2023; c) Lot:H1721R, Exp 12/31/2023, Lot: L0722E, Exp 5/31/2025.

Recall details

Recalling firm
Preferred Pharmaceuticals, Inc., Anaheim, CA
Quantity
a) 266 Bottles, b) not reported, c) 216 Bottles
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
March 23, 2023