Drug Enforcement D-188-2013

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.

Status

Terminated

Classification

Class III

Report Date

March 13, 2013

Termination Date

November 1, 2013

Product Information

Product description
Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.
Product quantity
43,464 bottles (3,622 cases)
Reason for recall
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Recall initiation reason
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Aaron Industries Inc
Address
11865 Alameda St, 11840 S Alameda ST

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-188-2013
Event ID
64298
Recall initiation date
January 18, 2013
Center classification date
March 7, 2013
Code info
Lot# 81198, 82183, 80797; FP-44-081-03884,
More code info