FDA Drug Recalls

Recalls / Class III

Class IIID-0388-2022

Product

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

Affected lot / code info
Lot #: AT2102065A, AT2102065B, Exp 04/2023.

Why it was recalled

Subpotent drug

Recalling firm

Firm
Dr. Reddy's Laboratories, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
107 College Rd E, N/A, Princeton, New Jersey 08540-6623

Distribution

Quantity
18336 cartons
Distribution pattern
USA Nationwide

Timeline

Recall initiated
2022-01-10
FDA classified
2022-01-19
Posted by FDA
2022-01-26
Terminated
2024-03-29
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0388-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls