D-186-2013 Class III Terminated
FDA drug recall D-186-2013 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: 35,652 bottles (2,971 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
- 35,652 bottles (2,971 cases)
Product Description
Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011
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# 68089, 68415, 70046, 700516, 70665, 71157, 71704, 80795; FP-38-081-57313; FP-38-041-57307