Lucky Ice mouthwash recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Lucky Ice Cool Mouthwash 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
Lucky Ice Cool Mouthwash, alcohol free, 16.9oz, 12 count, UPC 808829108989, 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
- Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.
- Manufacturer
- Diagnostica Stago, Inc.
- Category
- Drug — Oral care
- Affected units
- 438
Distribution
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