D-0381-2022 Class III Terminated
FDA drug recall D-0381-2022 was initiated by Dr. Reddy's Laboratories, Inc. on Jan 4, 2022 and is designated Class III. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated Oct 20, 2023). Affected quantity: 11,064 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 26, 2022
- Initiation Date
- Jan 4, 2022
- Termination Date
- Oct 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,064 boxes
Product Description
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.
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide in the USA
Code Information
Lot #s: AC2000968E, Exp. 8/31/2022; AC2103328A; AC2103330I, Exp. 1/31/2023; AC2106452B, Exp. 3/31/2023.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0381-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026