The Recall Desk
LowFDA (Drugs)·D-1287-2015·Announced 2015-08-12

GlaxoSmithKline Recalls Panadol Acetaminophen Extra Strength for Dissolution Failures

GlaxoSmithKline is recalling Panadol Extra Strength acetaminophen bottles in Puerto Rico and the Virgin Islands because the product failed dissolution specifications.

What this means for you

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 by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling Panadol (acetaminophen) Extra Strength, 500 mg, in 30, 60, and 100-count bottles. The recall was initiated because the product failed dissolution specifications. A total of 17,675 cases were distributed in Puerto Rico and the Virgin Islands.

The affected products are identified by specific lot numbers and expiration dates listed in the recall notice. The recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences.

Consumers with these products should stop using them and contact GlaxoSmithKline Consumer Healthcare for a refund or further instructions.

The recalled product

Product
Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080-7, NDC 0135-0135-03) and c) 100 count (UPC 1-03-53100-91090-6, NDC 0135-0135-04) bottles, Distributed by: GlaxoSmithKline Consumer Healthcare
Manufacturer
GlaxoSmithkline Consmer Healthcare
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
17,675

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 (8)

  • a) 13034 exp 10/31/15
  • 13222 and 13337 exp 11/30/15
  • 13611 and 13760 exp 2/29/15
  • 13953 exp 4/30/16
  • and 14542 exp 1/31/17
  • b) BT10114001 and BT10115001A exp 2/1/18
  • 13316 and 13438 exp 11/30/15 and 13880 exp 2/29/16
  • c) 13298 exp 11/30/15 and 13759 exp 4/30/16

Distribution

Distributed in 2 states:

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