Trandate FDA Alerts

Labetalol Hydrochloride Injection by Hospira: Recall - Potential For Cracked Glass At Rim Surface Of Vials

ISSUE: Hospira is voluntarily recalling 3 lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial (NDC 0409-2267-20), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus (NDC 0409-2267-25) to the hospital/institution level. Hospira, Inc. initiated this recall due to the discovery of cracks on the rim surface of vials for these lots, which is covered by the stopper and crimp seal.

Cracked vials may result in a lack of sterility assurance for the product. Use of or exposure to a non-sterile product may be associated with adverse events such as fever, chills, sepsis or invasive systemic infections in patients.

Product was distributed nationwide to wholesalers / retailers / hospitals in the United States and Puerto Rico from April 2017 to August 2017.

BACKGROUND: Labetalol Hydrochloride is an adrenergic receptor blocking agent indicated for the control of blood pressure (BP) in severe hypertension. It is administered by repeated intravenous (IV) injections or by slow IV infusion.

RECOMMENDATION: Hospira, Inc. has notified wholesalers/retailers/hospitals by recall letter to arrange for return of any recalled product.

Wholesalers/retailers/hospitals/institutions with an existing inventory of the lots 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 Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/23/2018 - Press Release - Hospira]

Labetalol Hydrochloride Injection 100 MG/20 ML (5MG/ML), 20 ML, Multidose Vial by Hospira: Recall - Visible Particulates

ISSUE: Hospira, Inc. will initiate a voluntary nationwide recall to the user level for one lot of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL) 20 mL Multidose Vial, NDC 0409-2267-20, Lot 36-225-DD, Expiration 12/01/2015. The recall is due to embedded particulate within the glass vial and visible particles floating in the solution. There is the potential for product to come into contact with embedded particles and the particles may become dislodged into the solution. The embedded particulate was identified as stainless steel and the floating particulate as iron oxide.

Blocked administration of the drug to the patient, causing a delay in therapy is possible. However, due to the size of the particulates identified, it is more likely that particulates are able to pass through the catheter and may cause injection site reactions and local irritation in the blood vessels, tissues and organs. While extremely rare, particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage.

BACKGROUND: Labetalol Hydrochloride Injection, USP is a clear colorless solution for intravenous administration and is indicated for control of blood pressure in severe hypertension. The recalled lot was distributed nationwide in the U.S. in February, 2014, to wholesalers/distributors, hospitals and clinics.

RECOMMENDATION: Anyone with an existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. For additional assistance, call Stericycle at 1-888-386-2076 (M-F, 8 a.m - 5 p.m. ET). For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/16/2014 - Firm Press Release - Hospira, Inc.]