D-419-2013 Class III Terminated
FDA drug recall D-419-2013 was initiated by Aaron Industries Inc on April 4, 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: 27,144 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 29, 2013
- Initiation Date
- April 4, 2013
- Termination Date
- November 1, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,144 bottles
Product Description
Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.
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 in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.
Code Information
Lot # 82507 and 82720.