Why it was recalled
Failed Dissolution Specifications
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Puerto Rico and Virgin Islands
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1287-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 30, 2015
- FDA report date
- Aug 12, 2015
- Quantity
- 17,675 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithkline Consmer Healthcare
Original FDA data
Every field from FDA enforcement report D-1287-2015, exactly as published.
Show all FDA fields
- City
- Moon Township
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 71717
- Address
- 1000 GSK Drive
- 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
- Postal code
- 15108
- Report date
- Aug 12, 2015
- Product type
- Drugs
- Recall number
- D-1287-2015
- Classification
- Class III
- Recalling firm
- GlaxoSmithkline Consmer Healthcare
- Product quantity
- 17,675 cases
- Termination date
- Feb 28, 2017
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Puerto Rico and Virgin Islands
- Recall initiation date
- Jun 30, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 5, 2015