The Food and Drug Administration issued Advisory 2014-049 where it warned against the use of Meparin 5 (1000 IU/ml) and Meparin 25 (5000 IU/ml).
It advised hospitals, health facilities and the general public to “stop the use” of these products manufactured by MedChem International Ltd – India, “regardless of the batch.”
Also, it advised government and commercial pharmacies to stop dispensing these particular drug products.
However, the FDA advisory dated June 25 did not specifically say if the two products could be behind the chills experienced by some patients at the NKTI last May.
Last Tuesday, a report on “24 Oras” said contaminated heparin is being eyed as the cause of the chills experienced by at least 44 patients at the NKTI last May.
The “24 Oras” report added the manufacturer and distributors of the contaminated brand had been notified, though the DOH at the time declined to identify the brand and manufacturer.
Quality problem
The FDA said it found Meparin 5 batch N-3176 contaminated with bacteria.
It earlier issued a recall order on Meparin 5 batches N-3176, and put other batches of this product on quality hold.
In a phone interview with GMA News Online on Thursday, Thelma Barros, company pharmacist of the brands’ distributor, Pharma-Surrey International, Inc., said that they conducted a voluntary recall of the said brands early this month, while the investigation at the NKTI was still ongoing.
They have also met with the FDA about the matter, she added.
Tests
Meanwhile, the FDA said it will do tests on all parenteral products manufactured by MedChem International Ltd.-India that are in the Philippine market.
It also said companies involved with this product that do not have a risk management plan should monitor their own products’ safety profile “and to take rapid action when there is a probable cause on safety breaches.”
“The accountability of companies in product quality and safety in this case is being studied by the FDA with end in view for levying appropriate penalties,” it said.
According to the FDA, consumers may contact Pharma-Surrey International Inc. at telephone number (+632) 412-8364, or e-mail it at pharmasurrey@yahoo.com.
It added consumers may also email the FDA at info@fda.gov.ph for any question or additional information regarding the product recall. — Joel Locsin and Rose-An Jessica Dioquino/BM, GMA News
