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Recall Observatory FDA recall evidence

Drug 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

D-0388-2022

January 10, 2022

Class III

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 89388
Status
Terminated
Classification
Class III
Quantity
18336 cartons
Official record key
drug-enforcement:D-0388-2022

Official wording

Reason: Subpotent drug

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

Distribution pattern: USA Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent