D-0380-2022 Class III Terminated

Recalled by Dr. Reddy's Laboratories, Inc. — Princeton, NJ

FDA drug recall D-0380-2022 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: 7,080 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
7,080 boxes

Product Description

Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India.

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: AC2103330D, Exp.1/31/2023; AC2106452E, 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-0380-2022
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.