Claritin Tablets Recalled Nationwide for Insanitary Distribution Center Conditions
Claritin 20-count tablets are being recalled nationwide by Gold Star Distribution Inc. due to insanitary conditions, including rodent exposure and activity, identified in their 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: This is an FDA Class II recall for CGMP deviations. The contamination risk from insanitary conditions and rodent exposure in the pharmaceutical distribution facility qualifies as a risk-of-harm scenario, meeting the rubric criterion for high severity.
Plain-English summary
Claritin 20-count tablets (UPC 655708016305) distributed nationwide by Gold Star Distribution Inc. are being recalled. The recall encompasses all product lots within their expiration dates that were distributed by Gold Star Distribution Inc.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations found in Gold Star Distribution Inc.'s distribution center. Specifically, insanitary conditions were identified, including evidence of rodent exposure and activity within the facility.
Consumers who have this product should discontinue use and consult their pharmacist or physician regarding proper disposal and alternative treatments. Those needing additional information can contact the FDA or their healthcare provider. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Claritin, 20 Count, UPC: 655708016305
- Manufacturer
- GOLD STAR DISTRIBUTION INC
- Category
- Drug
- Hazard
- insanitary-conditions
- rodent-exposure
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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