DayQuil Cold & Flu Recalled for Insanitary Manufacturing Conditions
Gold Star Distribution is recalling DayQuil Cold & Flu 32CT/2PK packages nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The distribution center was found to have insanitary conditions including rodent exposure and activity.
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: Per the rubric, FDA Class II recalls require hospitalization or significant injury reports to qualify as 'Severe.' This recall meets the 'High' criterion: a risk-of-harm product (drug with CGMP violations including rodent contamination potential) where injury has not yet been reported.
Plain-English summary
Gold Star Distribution Inc. is recalling DayQuil Cold & Flu, 32CT/2PK. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered at the company's distribution center. Investigators found insanitary conditions including evidence of rodent exposure and activity.
The affected product was distributed nationwide. This recall encompasses all lots of the product within their expiration date that were distributed by Gold Star Distribution.
Consumers who have purchased this product should discontinue use and consider contacting their retailer about a return or refund.
The recalled product
- Product
- DAYQUIL COLD & FLU, 32CT/2PK
- Manufacturer
- GOLD STAR DISTRIBUTION INC
- Category
- Drug — Over-the-Counter Cold/Flu
- Hazard
- cgmp-violation
- rodent-contamination
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)
- All lots within expiry distributed by Gold Star Distribution.
Distribution
Distributed nationwide across the United States.
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