Recalls / Class III
Class IIID-1287-2015
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
- Affected lot / code info
- 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
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- GlaxoSmithkline Consmer Healthcare
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1000 GSK Drive, N/A, Moon Township, Pennsylvania 15108
Distribution
- Quantity
- 17,675 cases
- Distribution pattern
- Puerto Rico and Virgin Islands
Timeline
- Recall initiated
- 2015-06-30
- FDA classified
- 2015-08-05
- Posted by FDA
- 2015-08-12
- Terminated
- 2017-02-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1287-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.