Drug product
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04
D-0302-2020
Product summary
- Event
- Event 83887
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,280 bottles
- Official record key
drug-enforcement:D-0302-2020
Official wording
Reason: Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Code information: Lot #: A972834374, Exp 12/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance