D-0388-2022 Class III Terminated

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

FDA drug recall D-0388-2022 was initiated by Dr. Reddy's Laboratories, Inc. on Jan 10, 2022 and is designated Class III. Reason for recall: Subpotent drug The recall status is terminated (terminated Mar 29, 2024). Affected quantity: 18336 cartons.

Recall Details

Product Type
Drugs
Report Date
Jan 26, 2022
Initiation Date
Jan 10, 2022
Termination Date
Mar 29, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18336 cartons

Product Description

Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3

Reason for Recall

Subpotent drug

Distribution Pattern

USA Nationwide

Code Information

Lot #: AT2102065A, AT2102065B, Exp 04/2023.

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0388-2022
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.