Infant ibuprofen drops are recalled nationwide for process-related particulates
McNeil Consumer Healthcare is recalling 197,532 bottles of Concentrated Motrin Infants' Drops because process-related particulates were observed. The affected bottles were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Score 3 applies because the notice identifies a risk-of-harm drug recall involving foreign particulates and does not report an injury. The FDA Class II classification does not meet the rubric's score-4 criterion because no hospitalizations are reported.
Plain-English summary
McNeil Consumer Healthcare is recalling Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor, in 1/2 fl oz bottles containing 50 mg per 1.25 mL. The recall covers 197,532 bottles distributed nationwide.
The affected lots are DCB3T01, DDB4R01, and DDB4S01, all expiring 03/31/15. The FDA classified the recall as Class II. The reason is the presence of process-related particulates, which may be associated with raw materials.
The notice does not state what consumers should do or report any illnesses or injuries.
The recalled product
- 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.
- Category
- Drug — Infant oral suspension
- Affected units
- 197,532
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: DCB3T01
- DDB4R01
- and DDB4S01
- Exp 03/31/15
Distribution
Distributed nationwide across the United States.
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