Alka Seltzer recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Alka Seltzer 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
Alka Seltzer, sold as Original with 2 tablets per packet in a 58-count box under UPCs 815556020033 and 016500514473, and Plus Cold & Flu with 2 tablets per packet in a 36-count box under UPC 016500594932, 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
- Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
- Manufacturer
- GOLD STAR DISTRIBUTION INC
- Category
- Drug — Antacid
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.
Part of a larger recall action
This product is one of 27 recalled by GOLD STAR DISTRIBUTION INC under a single FDA (Drugs) 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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