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: GlaxoSmithK

FDA recall notice · announced August 12, 2015 · Glaxosmithkline Consmer Healthcare

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 L.P, Moon Township, PA 15108

Reason for recall

Failed Dissolution Specifications

Notes

Distribution: Puerto Rico and Virgin Islands
Lot/code information: 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
Quantity: 17,675 cases
Status: Terminated
Products in this recall event:
- 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, (D-1287-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.