Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray,120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.Risk Statement: There is a potential for patients to be exposed to the glass particles and mechanical irritation cannot be ruled out. Local trauma to the nasal mucosa might occur with use of the defective product. To date, Apotex Corp. has not received any reports of adverse events related to recall.
Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays is indicated for the treatment of seasonal and perennial allergic rhinitis and for the management of sinus pain and pressure associated with allergic rhinitis in patients 4 to 17 years of age The affected Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays can be identified by the information in the table below: and on the product label:
NDC
Lot
Number
Expiration
Date
Strength
Configuration/Count
60505-0829-1
NJ4501
07/2020
50 mcg per
spray
120 Metered
Sprays
Carton containing 1 Bottle of 50
mcg per spray 120 Metered Sprays
The affected Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays was distributed nationwide to wholesalers and distributors.
Apotex Corp. has notified wholesalers/distributor by recall letter to arrange for return of any recalled product.
Consumers/wholesalers/retailers/hospitals/institutions with an existing inventory of the lot subject to this recall should stop use and distribution of the remaining units and quarantine immediately. Healthcare Professionals in your organization should be informed of this recall. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you. For additional assistance, call GENCO Pharmaceutical Services, a subsidiary of FedEx Supply Chain (GENCO) at 1- 877-475-5863 (7:00am – 5:00pm, CST Monday thru Friday), to arrange for return of the product.
Customers with questions regarding this recall can contact Apotex Corp. by phone-number 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Regular Mail or Fax: download form www.fda.gov/MedWatch/getforms.htm or call 1-800-FDA-1088 to request form, then complete and return address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Haggen has pulled El Monterey products with the following expiration dates from its shelves. These products have been specifically recalled:El Monterey Shredded Steak & Cheese Flour Taquitos, 28 oz – UPC: 71007-40389. Expiration Dates: 05/05/2014, 05/17/2014, 05/20/2014, 05/22/2014,
06/07/2014, 10/08/2014, 10/11/2014, 10/16/2014, 10/21/2014, 12/12/2014El Monterey Shredded Steak Corn Taquitos, 28 oz – UPC: 71007-40155. Expiration Dates: 08/15/2014, 08/16/2014, 10/18/2014, 11/11/2014, 12/12/2014, 12/13/2014Reason for Recall:
Ruiz foods is issuing a recall on certain best if used by dates of EL MONTEREY SHREDDED STEAK AND CHEESE FLOUR TAQUITOS 28 OZ. AND EL MONTEREY SHREDDED STEAK CORN TAQUITOS 28 OZ. The product was manufactured using meat that has been recalled by Rancho Feeding Company. There have been no reports of illnesses due to the consumption of this product.
All product may be returned for a full refund.
For more information, please call Ruiz Foods at 1-800-772-6474
The initiative contains important language regarding tips and service charges
The initiative states that an employer must pay to its employees:
All tips and gratuities; and
All service charges as defined under RCW 49.46.160(app.leg.wa.gov), except those that are itemized as not being payable to the employee or employees servicing the customer.
Tips and service charges paid to an employee may not offset the state minimum wage requirement.
Paid sick leave requirements
Starting January 1, 2018, employers in Washington will be required to provide their employees with paid sick leave.
Accrual
Paid sick leave must accrue at a minimum rate of one hour of paid sick leave for every 40 hours worked. This includes part-time and seasonal workers.
Paid sick leave must be paid to employees at their normal hourly compensation.
Employees are entitled to use accrued paid sick leave beginning on the 90th calendar day after the start of their employment.
Unused paid sick leave of 40 hours or less must be carried over to the following year.
Employers are allowed to provide employees with more generous carry over and accrual policies.
Usage
Employees may use paid sick leave:
To care for themselves or a family member.
When the employees’ workplace or their child’s school or place of care has been closed by a public official for any health-related reason.
Executive Administrative Professional (EAP) exemptions (Chapter 296-128 WAC, Minimum Wages)
Chapter 296-128, WAC
All updates for this rule:
The purpose of this rulemaking is to update Chapter 296-128 WAC, Minimum Wages, regarding exemptions for employees working in an executive, administrative, or professional capacity, or in the capacity of an outside salesperson. Most employees covered by the Washington Minimum Wage Act must be provided a minimum wage, overtime for working above forty hours in a seven-day workweek, and paid sick leave. The Minimum Wage Act exempts some workers from these requirements. RCW 49.46.010(3)(c) exempts any individual “employed in a bona fide executive, administrative, or professional capacity or in the capacity of outside salesperson as those terms are defined and delimited by rules of the director [of the department of Labor & Industries].” The department promulgated rules in 1976 for the executive, administrative, professional, and outside salesperson exemptions, defining salary thresholds and duties tests for an employee to be considered exempt from the Minimum Wage Act under RCW 49.46.010(3)(c). The department later promulgated an additional professional computer employees exemption, WAC 296-128-535, and other clarifying rules in WAC 296-128, which could be subject to revisions during this rulemaking. These exemption rules have been largely untouched since 1976, and currently exempt more workers than originally intended. Updating the rules would restore appropriate function to the exemption rules.
Enforcement for Paid Sick Leave and Retaliation (Initiative 1433) (Chapter 269-128 WAC, Minimum wages)
The purpose of this rulemaking is to adopt rules pertaining to the enforcement directives related to the implementation of Initiative 1433, An Act Related to Fair Labor Standard. Initiative 1433 passed on November 8, 2016, and requires, in part, employers provide paid sick leave to employees beginning on January 1, 2018. Initiative 1433 directs the Department to adopt and implement rules to carry out and enforce the act. The changes were adopted 12/19/2017 and became effective on 1/1/2018.
The purpose of this rulemaking is to implement, carry out, and enforce Initiative 1433, An Act Relating to Fair Labor Standards, which requires employers provide paid sick leave to employees. These rules: – Set parameters for the directives in Chapter 49.46 RCW; and – Create definitions and descriptions for paid sick leave pertaining to: written policies, accrual, usage, variance from required increments of use, reasonable notice, verification for absences exceeding three days, rate of pay, payment of paid sick leave, separation and reinstatement of accrued paid sick leave upon rehire, paid time off (PTO) programs, shared leave, shift swapping, frontloading, third party administrators, employee use of paid sick leave for unauthorized purposes, employer notification and reporting to employees, and retaliation. In addition to the paid sick leave proposed rules, amendments are being made to rules updating outdated language concerning people with disabilities to “People-first” language. Enforcement of the retaliation and enforcement directives related to the implementation of Initiative 1433 are being addressed in a separate rulemaking. The department will be working with employee and employer representative to perform outreach about the new rules. An online employer resource center is being developed to assist employers in learning about their new requirements, to provide guidance on employee notification and sample policies, etc. This rulemaking’s effective date is January 1, 2018, the effective date of the paid sick leave provisions of Initiative 1433. The changes were adopted 10/17/2017 and became effective on 1/1/2018.
You must be logged in to post a comment.