The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-216-2013·Announced 2013-04-03

L. Perrigo Recalls Subpotent PE Daytime Cold/Flu LiqGel Blister Packs

L. Perrigo is recalling 60,048 blister packs of PE Daytime Cold/Flu LiqGel because the active ingredient Phenylephrine HCl was subpotent at the 12-month time point.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a subpotent ingredient, which is a quality defect rather than a direct safety hazard like contamination or mislabeling of a dangerous substance.

Plain-English summary

L. Perrigo Co. is recalling 60,048 blister packs of PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps. The product is distributed by Wal-Mart Stores Inc. in Bentonville, AR. The specific lot code is 2 AE1549 with an expiration date of 02/13.

The recall was initiated because the active ingredient Phenylephrine HCl was found to be subpotent at the 12-month time point. This means the medication may not contain the full amount of the active ingredient required to provide the intended therapeutic effect.

Consumers who have this specific product should stop using it and return it to the point of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716
Manufacturer
L. Perrigo Co.
Category
Drug — Cold and Flu Medication
Hazard
Affected units
60,048

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)

  • 2 AE1549 Exp. 02/13

Distribution

Distribution scope not specified by the agency.

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