FDA Drug recall D-0378-2022
Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended…
- FDA Drug
- Class III
- terminated
- Published 2022-01-26
On 2022-01-26 the FDA classified a Class III recall of Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended… by Dr Reddy S Laboratories, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0378-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-01-04 |
| Published | 2022-01-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
Failed Dissolution Specifications
Identifiers
| ndc | 0363-1606-30 |
|---|---|
| ndc | 0363-1606-20 |
| code_info | Lot #s: a) (20-count box): AC2000968D, Exp. 8/31/2022; AC2103330J, Exp. 1/31/2023; AC2106452A; AC2106452H, Exp. 3/31/…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0378-2022%22
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