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Recall Observatory FDA recall evidence

Drug product

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

D-186-2013

January 18, 2013

Class III

Product summary

Firm
Aaron Industries Inc
Event
Event 64298
Status
Terminated
Classification
Class III
Quantity
35,652 bottles (2,971 cases)
Official record key
drug-enforcement:D-186-2013

Official wording

Reason: 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.

Code information: Lot# 68089, 68415, 70046, 700516, 70665, 71157, 71704, 80795; FP-38-081-57313; FP-38-041-57307

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.