Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), Rx on...

FDA Drug Recall #D-1362-2015 — Class II — August 13, 2015

Recall Summary

Recall Number D-1362-2015
Classification Class II — Moderate risk
Date Initiated August 13, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm GlaxoSmithKline, LLC.
Location Zebulon, NC
Product Type Drugs
Quantity 166,070 of 15g tube, 112,720 of 30 g tube

Product Description

Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), 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

Lot / Code Information

Lot #: C690076, C693373, Exp 2/2016; Lot #: C701378, C701376, Exp 4/2016; Lot #: C704164, Exp 5/2016; Lot #: C713687, Exp 8/2016; Lot #: C719467,C718203, Exp 9/2016; Lot #: C723641, Exp 10/2016; Lot #: C683884, Exp 12/2016; Lot #: C697653, Exp 3/2016; Lot #: C710477, Exp 7/2016; Expanded to include: C697654, Exp. 03/2016 (15 grams), C723642, Exp. 10/2016 (30 grams).

Other Recalls from GlaxoSmithKline, LLC.

Recall # Classification Product Date
D-1360-2015 Class II Bactroban Ointment (mupirocin calcium), 2% 22g ... Aug 13, 2015
D-1361-2015 Class II Bactroban Cream (mupirocin calcium), 2%, a) 15g... Aug 13, 2015
D-1359-2015 Class II Bactroban (mupirocin calcium) Nasal Ointment, 2... Aug 13, 2015
D-388-2014 Class II Sumatriptan Succinate Injection, 6 mg, 0.5 mL F... Nov 6, 2013
D-387-2014 Class II Imitrex STATdose System, Imitrex (sumatriptan s... Nov 6, 2013

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.