Recalls / Class III
Class IIID-0378-2022
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.
- Brand name
- Fexofenadine Hcl And Pseudoephedrine Hci
- Generic name
- Fexofenadine Hcl And Pseudoephedrine Hci
- Active ingredients
- Fexofenadine Hydrochloride, Pseudoephedrine Hydrochloride
- Route
- Oral
- NDC
- 0363-1606
- FDA application
- ANDA076667
- Affected lot / code info
- 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.
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Walgreens Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 67,848 boxes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-01-04
- FDA classified
- 2022-01-18
- Posted by FDA
- 2022-01-26
- Terminated
- 2023-10-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0378-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.