The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed that AuroMedics Pharma is voluntarily recalling one lot of Ampicillin and Sulbactam for injection USP, 1.5g in a single -dose vial (equivalent to 1g ampicillin as the sodium salt plus 0.5g Sulbactam as the sodium salt) due to the presence of glass particles in the vial.
The administration of a glass particles, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting of blood vessels, which may be life threatening.
The Ampicillin and Sulbactam for injection is used for the treatment of infections due to susceptible strains of designated microorganism in skin and skin structure infections, intra-abdominal infections and gynecological infections in adult and for treatment of skin and skin structure infection in pediatric patient one year and older.
RECALLED PRODUCT DETAILS
| Brand Name | Expiration Date | Lot No: | Size Pack | Description: |
| Ampicillin and Sulbactam for injection USP 1.5G | DEC 2018 | LOT AFOL 17001-A | 1.5g in a single dose vial. | Clear vial stoppered with grey rubber stopper and sealed with aluminum seals having a royal blue color polypropylene disc. |
Recommended Actions:
- Healthcare providers and Customers that have the product lot which is being recalled should immediately stop their use and submit to the nearest NAFDAC office.
- Healthcare providers and patients should report adverse events associated with the use of these products to the nearest NAFDAC office, NAFADC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng
NAFDAC……….Safeguarding the health of the Nation
