Medline Acetaminophen Tablets Recalled for Incorrect Strength Labeling
Medline Industries is recalling 325 mg acetaminophen tablets that are actually 500 mg due to a labeling error.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Medline Industries, Inc. is recalling specific bottles of Acetaminophen Regular-Strength Pain Reliever tablets. The recall involves 100-count bottles labeled as containing 325 mg tablets, but which actually contain 500 mg tablets. The affected product is identified by NDC 53329-642-30, Lot # 45810, and an expiration date of 05/18.
The recall was initiated because of a labeling error where the declared strength on the bottle did not match the actual tablet strength. This discrepancy could lead to consumers taking a higher dose of acetaminophen than intended if they follow the dosing instructions for the 325 mg strength.
The product was distributed nationwide. Consumers who have this specific product should stop using it and contact Medline Industries for further instructions or a refund.
The recalled product
- Product
- ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30.
- Manufacturer
- Medline Industries Inc
- Hazard
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 (2)
- lot # 45810
- Exp. 05/18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Medline Industries 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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