March 2022 FDA Recall Drug by Aptapharma Inc.
D-0787-2022 - Incorrect/Undeclared Excipient

This Class III drug recall was voluntarily initiated by Aptapharma Inc. on March 29, 2022 for the product Drug. The FDA reported the reason for recall as incorrect/undeclared excipient. The product was distributed in IL only and the recall is currently terminated.

Recall Number: D-0787-2022

Reason for Recall
Incorrect/Undeclared Excipient: Product contains alcohol
Initiated
03-29-2022
Reported
05-04-2022
Quantity
40000 - 50000 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89905
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AptaPharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
IL only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-24-2024
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# All lots