TUMS Antacid Tablets Recalled Due to Insanitary Conditions in Distribution Center
TUMS antacids manufactured by Gold Star Distribution Inc are being recalled due to insanitary conditions including rodent exposure in the distribution center. No illnesses have been reported.
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: FDA classified this as a Class II recall. The hazard—insanitary conditions with rodent exposure in the distribution center—represents a risk of contamination, but no illnesses or injuries have been reported. This meets the rubric's High (3) criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
TUMS antacid tablets in multiple formulations (Assorted 12-count, Extra Strength Assorted Berries 12-count, and Extra Strength Assorted Fruit 12-count) manufactured and distributed by Gold Star Distribution Inc are being recalled.
The recall is due to insanitary conditions in Gold Star Distribution's distribution center, including rodent exposure and activity. These conditions represent violations of current good manufacturing practices (CGMP).
The affected products were distributed nationwide. All lots within their expiration date that were distributed by Gold Star Distribution are included in the recall.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27
- Manufacturer
- GOLD STAR DISTRIBUTION INC
- Category
- Drug — Antacid
- Hazard
- rodent-contamination
- insanitary-conditions
- cgmp-deviation
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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