The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public that Alvogen is conducting a voluntary recall of seven (7) lots of Clindamycin Injection USP ADD-Vantage Vials, manufactured for Alvogen by Hospira Inc., to the hospital or retail level.
Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible bacteria. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate.
Reason for recall
On June 16, 2017, Alvogen announced that it was voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials in response to microbial growth detected during a routine manufacturing simulation. This growth shows the potential for possible contamination of product. Hospira, a Pfizer company, also recalled several other products for the same reason.
Possible associated risk
According to NAFDAC, the administration of this product may cause adverse events, ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.
Details of affected products
| Lot number | Expiration Date | Strength | NDC # |
| 68-104-EV | 07/31/2018 | 600mg/4mL | 47781-463-69 |
| 68-105-EV | 07/31/2018 | 900mg/6mL | 47781-464-69 |
| 68-106-EV | 07/31/2018 | 900mg/6mL | 47781-464-69 |
| 73-154-EV | 12/31/2018 | 300mg/2mL | 47781-462-69 |
| 73-155-EV | 12/31/2018 | 600mg/4mL | 47781-463-69 |
| 73-156-EV | 12/31/2018 | 600mg/4mL | 47781-463-69 |
| 73-157-EV | 12/31/2018 | 900mg/6mL | 47781-464-69 |
Healthcare providers’ action
- Healthcare providers in possession of the affected lots of product should discontinue their use and submit them to the nearest NAFDAC office.
- Healthcare providers and patients should report adverse reactions associated with the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR 920543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng
