Why it was recalled
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Product description
Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217.
Lot numbers, UPCs & expiration codes
15 g: Lot #: C695549, Exp 03/2016; 30 g: Lot #: C707836, Exp 7/2016; C718209, Exp 9/2016, Expanded to include: C707837, Exp. 07/2016, C718210, Exp. 09/2016.
Where it was sold
Nationwide and Puerto Rico
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-1361-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 13, 2015
- FDA report date
- Sep 2, 2015
- Quantity
- 28,480 tubes of 15g, 12,234 tubes of 30g
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- GlaxoSmithKline, LLC.
Original FDA data
Every field from FDA enforcement report D-1361-2015, exactly as published.
Show all FDA fields
- City
- Zebulon
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 71920
- Address
- 1011 North Arendell Ave
- Code information
- 15 g: Lot #: C695549, Exp 03/2016; 30 g: Lot #: C707836, Exp 7/2016; C718209, Exp 9/2016, Expanded to include: C707837, Exp. 07/2016, C718210, Exp. 09/2016.
- Postal code
- 27597-1217
- Report date
- Sep 2, 2015
- Product type
- Drugs
- Recall number
- D-1361-2015
- Classification
- Class II
- Recalling firm
- GlaxoSmithKline, LLC.
- Product quantity
- 28,480 tubes of 15g, 12,234 tubes of 30g
- Termination date
- Mar 21, 2017
- Reason for recall
- Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Aug 13, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 25, 2015