GlaxoSmithKline recalls over 30 batches of antibiotic cream due to glass, rust contamination
MANILA — Pharmaceutical firm GlaxoSmithKline (GSK) Philippines has voluntarily recalled more than 30 batches of an antibiotic topical cream as a precautionary measure against potential contamination of glass particles, rust and paint chips, the Food and Drug Administration (FDA) said.
In an advisory, the FDA said GSK Philippines was recalling 31 batches of Mupirocin Calcium (as Free Acid) 20 mg/g Cream (Bactroban 2%) due to particulate contamination as observed by the United States FDA.
The FDA identified the affected batches with their respective expiry dates as: 4BC26A, March 2016; 5BC06, August 2016; 4BC27, March 2016; 5BC07, August 2016; 4BC29, April 2016; 5BC08, August 2016; 4BC32, April 2016; 5BC10, August 2016; 4BC33, April 2016; 5BC11, September 2016;
* 4BC34, April 2016; 5BC12, September 2016; 4BC35A, May 2016; 5BC13, September 2016; 4BC36, May 2016; 5BC14, September 2016; 4BC37, May 2016; 5BC15A, September 2016; 4BC38, May 2016; 5BC19, October 2016; 4BC39, May 2016; 5BC20, October 2016; 4BC42A, June 2016;
* 5BC21, October 2016; 5BC01, June 2016; 5BC22, November 2016; 5BC02, July 2016; 5BC23, December 2016; 5BC03, July 2016; 5BC23A, December 2016; and 5BC04, July 2016.
The FDA said the voluntary recall was initiated on the product due to the possibility of contamination of glass particles, paint chips, rust and certain fibers from cleaning material and personnel clothing.
Mupirocin Calcium is used for the topical treatment of secondary infected traumatic lesions such as small lacerations, sutured wounds or abrasions. The product is packed in an aluminum tube in 2.5 grams as physician’s sample; 5.0 grams and 15.0 grams in boxes of 1’s.
“The affected product batches present possibilities of sensitization or local irritation from the presence of the said physical contaminants,” warned the FDA.
“Therefore, distributors, retailers, hospitals, pharmacies or clinics that have the affected batches of the drug product are instructed to discontinue further distribution, sale and use,” it added.
It also advised consumers against purchasing the affected product batches. SFM
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