Recalls / Class III
Class IIID-0381-2022
Product
Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release Tablets USP, 20 tablets per box, NDC 30142-611-14, Distributed by the Kroger Co., Cincinnati, Ohio, 45202, 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
- 30142-611
- FDA application
- ANDA076667
- Affected lot / code info
- Lot #s: AC2000968E, Exp. 8/31/2022; AC2103328A; AC2103330I, Exp. 1/31/2023; AC2106452B, Exp. 3/31/2023.
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- The Kroger Co.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 11,064 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-0381-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.