Drug recall D-0378-2022

Class III Terminated reported Jan 26, 2022

Product

Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in India.

Reason for recall

Failed Dissolution Specifications

Lots and codes

Lot #s: a) (20-count box): AC2000968D, Exp. 8/31/2022; AC2103330J, Exp. 1/31/2023; AC2106452A; AC2106452H, Exp. 3/31/2023. b) (30-count box): 79C002624C, Exp. 4/30/2022; AC2103328B; AC2103328C; AC2103330A; AC2103330B, Exp. 1/31/2023.

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
67,848 boxes
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
January 4, 2022
Terminated
October 20, 2023

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