D-185-2013 Class III Terminated
FDA drug recall D-185-2013 was initiated by Aaron Industries Inc on January 18, 2013 and is designated Class III. 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. The recall status is terminated (terminated November 1, 2013). Affected quantity: 6,108 bottles (509 cases).
Recall Details
- Product Type
- Drugs
- Report Date
- March 13, 2013
- Initiation Date
- January 18, 2013
- Termination Date
- November 1, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,108 bottles (509 cases)
Product Description
Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08
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.
Distribution Pattern
Nationwide
Code Information
Lot# 80798; FP-49-081-14870,