Swan rubbing alcohol recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Swan White Clear Alcohol over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
What this means for you
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
Swan White Clear Alcohol, 50%, 16oz, 12 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
- Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suita
- Manufacturer
- Heraeus Medical GmbH (Dental Division)
- Category
- Drug — Rubbing alcohol
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 (2)
- Lot Code: UDI-DI: 04260102136243
- 04260102136274
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Heraeus Medical GmbH (Dental Division) 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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