Equate ClearLAX Recalled for Unfiled NDC Numbers on Labeling

Plain-English summary

Lupin Somerset is recalling 2,229,052 bottles of Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, an over-the-counter osmotic laxative. The product is distributed by Walmart Stores, Inc., and is available in 119 g and 238 g bottle sizes. The recall is nationwide.

The recall was initiated because a private label distributor noted unfiled National Drug Code (NDC) numbers on the product labels. This is a labeling issue classified as 'Not Elsewhere Classified.' The FDA has classified this as a Class III recall, which indicates that the product is not likely to cause adverse health consequences or death.

Consumers with this product should check the lot numbers and expiration dates listed in the recall notice to determine if their bottles are affected. Since this is a labeling error with no reported health hazards, consumers can return the product to the place of purchase for a refund or follow instructions from the manufacturer.

The recalled product

Product

Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716

Manufacturer

LUPIN SOMERSET

Category

Drug — Over-the-Counter Laxative

Hazard

• mis-labeling

Affected units

2,229,052

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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