Drug product
Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08
D-185-2013
Product summary
- Event
- Event 64298
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6,108 bottles (509 cases)
- Official record key
drug-enforcement:D-185-2013
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# 80798; FP-49-081-14870,
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.