Voluntary Recall of Vancomycin
HCI 750 mg & 1 gm Vials
December 5, 2018
Potential for these lots to contain vials with high and low fill weights for the lyophilized product.
Please be advised that Hospira, Inc., a Pfizer company ("Hospira") has issued a voluntary recall of Vancomycin 750 mg and 1 gm vials.
According to the manufacturer, this recall has been initiated due to the potential for these lots to contain vials with high or low fill weights for the lyophilized product.
Pfizer completed a Health Hazard Assessment which concluded that the use of the impacted product has a reasonable probability of being administered to the patient at a sub-therapeutic or more potent dosage that may result in lack of efficacy, antibiotic resistance or severe adverse events such as ototoxicity and nephrotoxicity. The overall potential risk for patients arising from this quality issue is considered to be high.
Vancomycin 750 mg and 1 gm vials
NDC Number | Lot Number | Expiry Date | Strength |
00409-6531-02 | 840053A | 12/01/2019 | 750 mg |
00409-6533-01 | 840103A | 12/01/2019 | 1 gm |
00409-6533-01 | 842313A | 12/01/2019 | 1 gm |
Only the Vancomycin lots listed above are subject to this notification. All other lots on the market are unaffected and may continue to be used.
Anyone with an existing inventory of Vancomycin 750 mg or 1 gm should determine whether they have product from the recalled lots, quarantine and discontinue distribution of the affected product.
If you have affected lots of Vancomycin, please contact Wow! Customer Care to begin the returns process.
If you already received notification and returned the product to FFF Enterprises, no action is required.
For assistance, please call Wow! Customer Care at (800) 843-7477.