Medicine recalls
|
| |
| The United States: Novartis issues voluntary nationwide recall of Promacta® 12.5 mg for Oral Suspension due to potential peanut contamination |
| |
The US Food and Drug Administration (FDA) announces that Novartis is voluntarily recalling 3 lots of Promacta (eltrombopag) 12.5 mg for Oral Suspension to the consumer level. The oral suspension lots are being recalled because of a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site. The affected lots are:
- Lot number: 8H57901589; Expiration date: 09/2020
- Lot number: 9H57900189 ; Expiration date:12/2020
- Lot number: 9H57900289 ; Expiration date:12/2020
Promacta Tablets in 12.5 mg, 25 mg, 50 mg and 75 mg strengths are not impacted by this recall and are not manufactured in the same facility.
Peanut is a known food allergen. Potential cross contamination with peanut flour, even in small traces, can lead to hypersensitivity reaction in a population of patients with an unknown or known sensitivity to peanut antigen, including a medically significant anaphylactic reaction, which can be fatal.
To date, Novartis has not received any reports or adverse events for this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-nationwide-recall-promactar-125-mg-oral-suspension-due-potential-peanut
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, May 14, 2019
Issued at HKT 16:00
|
| |
