Share this Post!

All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holder (MAH) on the affected batches of the subject product from the market. The details of the products are as follows:

DRUG PRODUCT CEFEPIME (AS HYDROCHLORIDE)
DOSAGE STRENGTH 1 G POWDER FOR INJECTION (I.M./I.V.) 2 G POWDER FOR INJECTION (I.M./I.V.)
REGISTRATION NO. DR-XY35933 DR-XY35932
PACKAGING USP Type III Flint Glass Vial with Royal Blue Flip-Off Seal x 15mL (Box of 1’s) USP Type III Flint Glass Vial with Royal Blue Flip-Off Seal x 20mL (Box of 1’s)
BATCH NO./

EXP. DATE

SEE ATTACHED LIST
MANUFACTURER ASTRAL STERITECH PVT. LTD.- India
IMPORTER & DISTRIBUTOR RITEMED PHILS., INC.- 56 Epifanio Delos Santos Ave., Mandaluyong, Metro Manila

Cefepime is a semi-synthetic, broad spectrum, fourth generation cephalosporin for parenteral administration which is active against a wide range of Gram-positive, Gram-negative aerobic organisms and certain anaerobes. It exerts bactericidal effect by inhibiting the synthesis of the bacterial cell wall.

The MAH pursued the voluntary recall of the drug product due to an Out-of-Specification (OOS) data observed during a routine environmental monitoring at the manufacturer’s facility located in Vadodara, Gujarat, India. Due to the Good Manufacturing Practice (GMP) issues on the manufacturer’s sterile facilities, the integrity of the specific batches produced could no longer be assured and could relatively cause health risks to the patients. Thus, the stated batches present quality and safety concerns.

Distributors, hospitals, retailers, pharmacies, or clinics are therefore instructed to discontinue further distribution, sale, and use of the affected batches of the drug product. All consumers are likewise advised not to purchase or use the affected product batches and may contact RiteMED Phils., Inc through ask@ritemed.com.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 batches are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at cdrr_postmarketsurveillance@fda.gov.ph. To report continuous sale or distribution of the abovementioned, kindly e-mail us via ereport@fda.gov.ph. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the products should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.

Dissemination of the information to all concerned is requested.

Attachments