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FDA Advisory No. 2018-190

All Healthcare professionals and the general public are hereby warned by the Food and Drug Administration (FDA) that s specific lot of the subject product is being recalled from the market. The details of the product are as follows:

DRUG PRODUCT ALLOPURINOL 300 MG TABLET (ALLUJEN)
REGISTRATION NUMBER DRP-2173-01
LOT NUMBER / EXPIRY DATE SJN077 / SEPTEMBER 2018
MANUFACTURER NEW MYREX LABORATORIES, INC – BO. CATMON, STA. MARIA BULACAN
DISTRIBUTOR (Market Authorization Holder [MAH]) SKPD JEN, INC. – 3RD FLR. 44-A ANNAPOLIS ST., BRGY E. RODRIGUEZ, CUBAO, QUEZON CITY

Based on the results of the laboratory analyses conducted by the FDA, it was found that the affected lot did not conform to the set specification of hardness test. The hardness of an immediate-release tablet should be such that the tablet will be able to withstand the rigors of manufacturing, packaging, shipping, and distribution of the drug product. The stated lot presents quality concerns since it failed to meet specifications set by the manufacturer.

Allopurinol is indicated in the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy), in the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels, and in the management of patients with recurrent calcium oxalate calculi whose daily uric acid secretions exceeds 80 mg/day in male patients and 750 mg/day in female patients. Allopurinol 300 mg tabler (Allujen) is packed in aluminum-clear PVC Blister pack x 10’s (box of 100’s)

Thereof, distributors, hospitals, retailers, pharmacies or clinics that have affected lot of the drug product are instructed to discontinue further distribution, sale and use. All consumers are likewise advised not to purchase or use the affected product lot and may contact New Myrex Laboratories or SKP Jen, Inc at Telephone numbers +632 912 8034 / +632 400 8224 / +632 9134718 / +63922 8608151 or email us at cdrr_prsdd@fda.gov.ph for any question or additional information regarding the recall.

All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product is not sold or made available in their localities or are of jurisdiction.

Any suspected adverse reaction experienced from the use of aforementioned product lot should be reported immediately to FDA through this link: https://ww2.fda.gov.ph/index.php/adr-report-new and fill-out all of the required fields.

Dissemination of the information to all concerned requested.