D-0787-2022 Class III Terminated

Recalled by AptaPharma Inc. — Pennsauken, NJ

FDA drug recall D-0787-2022 was initiated by AptaPharma Inc. on March 29, 2022 and is designated Class III. Reason for recall: Incorrect/Undeclared Excipient: Product contains alcohol The recall status is terminated (terminated April 24, 2024). Affected quantity: 40000 - 50000 units.

Recall Details

Product Type
Drugs
Report Date
May 4, 2022
Initiation Date
March 29, 2022
Termination Date
April 24, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40000 - 50000 units

Product Description

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.

Reason for Recall

Incorrect/Undeclared Excipient: Product contains alcohol

Distribution Pattern

IL only

Code Information

All lots