Drug product
Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50 mg per 1.25ml, Distributed by McNeil Consumer Healthcare, Fort Washington, PA.
D-66272-001
Product summary
- Event
- Event 66272
- Status
- Terminated
- Classification
- Class II
- Quantity
- 197,532 bottles
- Official record key
drug-enforcement:D-66272-001
Official wording
Reason: Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
Code information: Lot #: DCB3T01, DDB4R01, and DDB4S01, Exp 03/31/15
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance