phenylephrine FDA Alerts
The FDA Alert(s) below may be specifically about phenylephrine or relate to a group or class of drugs which include phenylephrine.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for phenylephrine
Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination
Oct 21, 2017
Audience: Pharmacy, Health Professional
ISSUE: SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. There is a potential for the products to contain microbial contamination. See the recall notice for a full list of products.
BACKGROUND: Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. SCA Pharmaceuticals has not received any customer complaints or reports of adverse events related to this issue.
RECOMMENDATION: SCA Pharmaceuticals is notifying its customers via telephone, email and US mail and is arranging for return/replacement of all recalled products. Customers that have product which is being recalled, as indicated in the list above, should discontinue use immediately and return the product to SCA Pharmaceuticals.
Consumers with questions regarding this recall can contact SCA Pharmaceuticals at 877-550-5059, between the hours of 8:00 am and 5:00 pm (Central Standard Time), Monday thru Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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.
[10/20/2017 - Recall Notice - SCA Pharmaceuticals]
More phenylephrine Resources
- Phenylephrine Consumer Information
- Phenylephrine Tablets Consumer Information
- Phenylephrine Injection Consumer Information
- Phenylephrine Liquid Consumer Information
- Phenylephrine Intravenous Advanced Consumer Information
- Phenylephrine Hydrochloride AHFS DI Monograph
- Phenylephrine Hydrochloride Injection Prescribing Information
- Phenylephrine (Systemic) A-Z Drug Facts