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Recall Observatory FDA recall evidence

Drug product

Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0324-28.

D-0787-2022

March 29, 2022

Class III

Product summary

Firm
AptaPharma Inc.
Event
Event 89905
Status
Terminated
Classification
Class III
Quantity
40000 - 50000 units
Official record key
drug-enforcement:D-0787-2022

Official wording

Reason: Incorrect/Undeclared Excipient: Product contains alcohol

Code information: All lots

Distribution pattern: IL only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect/Undeclared Excipient: Product contains alcohol