# FDA recall D-0385-2022

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2022-01-04.

## Product

CVS Health,  Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India.

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0385-2022
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-01-04
- **Report date:** 2022-01-26
- **Termination date:** 2023-10-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0385-2022

## Citation

> AI Analytics. FDA recall D-0385-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0385-2022. Source: US FDA. Licensed CC0.

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