Drug product
Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-5), Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA.
D-187-2013
Product summary
- Event
- Event 64298
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,676 bottles (473 cases)
- Official record key
drug-enforcement:D-187-2013
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# 71648, 68088; FP-47-041-02535
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.