D-1361-2015 Class II Terminated
FDA drug recall D-1361-2015 was initiated by GlaxoSmithKline, LLC. on August 13, 2015 and is designated Class II. Reason for recall: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. The recall status is terminated (terminated March 21, 2017). Affected quantity: 28,480 tubes of 15g, 12,234 tubes of 30g.
Recall Details
- Product Type
- Drugs
- Report Date
- September 2, 2015
- Initiation Date
- August 13, 2015
- Termination Date
- March 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,480 tubes of 15g, 12,234 tubes of 30g
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.
Reason for Recall
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Distribution Pattern
Nationwide and Puerto Rico
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.