Drug product
Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.
D-188-2013
Product summary
- Event
- Event 64298
- Status
- Terminated
- Classification
- Class III
- Quantity
- 43,464 bottles (3,622 cases)
- Official record key
drug-enforcement:D-188-2013
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# 81198, 82183, 80797; FP-44-081-03884,
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.