Motrin dispensers recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Motrin 2's dispensers over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
The agency’s classification
FDA (Devices): 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: Scored 3 under the risk-of-harm criterion: the record cites insanitary conditions with rodent activity affecting distributed product, and no illnesses are reported.
Plain-English summary
Motrin 2's dispensers, 50 count distributed by Gold Star Distribution Inc is being recalled.
The reason given in the enforcement record is CGMP deviations: insanitary conditions including rodent exposure and activity in the firm's distribution center.
The recall covers all lots within expiry distributed by Gold Star Distribution. The record does not state a quantity. Distribution was nationwide in the US. The FDA has classified the action as Class II.
Consumers who have this product should not use it and should follow the retailer's return instructions.
The recalled product
- Product
- MAXXUS, System, Tomography, Computed, Emission
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Category
- Drug — Analgesic
- Affected units
- 38
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 (1)
- UDI/DI Not applicable: All serial numbers in distribution
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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