- Firm Announcement Date:
- December 17, 2018
- FDA Publish Date:
- June 06, 2019
- Product Kind:
- Motive for Announcement:
- Firm Title:
- Asclemed USA Inc dba Envoachem Pharmeceuticals
- Model Title:
Envoachem Prescribed drugs
- Product Description:
Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 plenty of Dyural-40 and 61 plenty of Dyural-80, to the person stage. The merchandise embody recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled because of product labeling incorrectly stating stoppers don’t comprise latex.
For the inhabitants most in danger, these with a extreme allergic response to latex, there may be chance of an anaphylactic response, and this might lead to hospitalization or dying. So far, Asclemed USA Inc has not obtained any experiences of adversarial occasions associated to this recall.
The merchandise are Dyural-40 comfort kits packaged in plastic trays and Dyural-80 comfort kits packaged in plastic trays, containing Sodium Chloride, USP, 0.9% by Fresenius Kabi.
The affected Dyural-40 heaps embody the next:
The affected Dyural-80 heaps embody the next:
The merchandise will be recognized by lot and expiration stamped on the entrance of every comfort package. Product was distributed Nationwide to distributors and physicians.
Asclemed USA Inc is notifying its distributors and prospects by e-mail and is arranging for return of all recalled merchandise. Distributors and physicians which have Dyural-40 or Dyural-80 which is being recalled ought to cease utilizing them and return to position of buy.
Customers with questions relating to this recall can contact Asclemed USA Inc by calling (310) 320-0100 ext. 120 Monday via Friday from 7:30am to 4:00pm PST or emailing firstname.lastname@example.org. Customers ought to contact their doctor or healthcare supplier if they’ve skilled any issues that could be associated to taking or utilizing this drug product.
Hostile reactions or high quality issues skilled with using this product could also be reported to the FDA’s MedWatch Hostile Occasion Reporting program both on-line, by common mail or by fax.
This recall is being carried out with the data of the U.S. Meals and Drug Administration.
Firm Contact Info
- Christina Hopson
- (310) 320-0100 ext. 120