The National Agency for Food and Drug Administration and Control has been informed by the U.S Food and Drug Administration (FDA), that Hospira voluntarily recalled one lot of Vancomycin Hydrochloride for injection, USP, 750mg/vial to the hospital/ retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass in a single vial.
The administration of the particulate to a patient may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma.
Vancomycin Hydrochloride is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci.
The details of the recalled product are as follows;
Product Name -Vancomycin Hydrochloride for inj. USP, 750mg/vial.
Product Manufacturer – Hospira Inc.
Lot Number – 632153A
Expiry Date – 01 MAR 2018
NDC– 0409-6531-02
Healthcare Provider’s Action
Healthcare Providers should visually inspect the product for particulate matter and discoloration prior to administration.
Healthcare Providers in possession of this batch of the product should immediately stop administration, sale or use of the product and submit them to the nearest NAFDAC office.
Healthcare providers and patients should report adverse reactions associated with the use of these product to the nearest NAFDAC office, NAFDAC PRASCOR 920543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng
NAFDAC…………Safeguarding the health of the Nation
