Drug Safety Alerts

Phytonadione Injectable Emulsion Class I Recall

4/08/2020

On April 8, 2020, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall of Phytonadione Injectable Emulsion manufactured by Dr. Reddy’s Laboratories. Dr. Reddy’s issued this recall was issued after receiving complaints of ampules breaking and shattering upon opening and compounding, resulting in injuries to healthcare professionals. This could pose a health hazard or safety risk to individuals using product affected by this recall.

A list of the affected products is provided here.

Dr. Reddy’s Laboratories has notified its distributors to arrange for return of any recalled product. Wholesalers, distributors, hospitals and pharmacies with an existing inventory of the lot being recalled, should stop use and distribution of the product and quarantine the product immediately for return or replacement of all recalled products. Wholesalers, distributors and pharmacies that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them. For instructions on returning product or additional assistance, call Inmar at 1-800-967-5952 between the hours of 8 a.m. to 5 p.m. EST, Monday through Friday.

Consumers with general questions can contact Dr. Reddy’s Laboratories 1-866-733-3952 between the hours of 8 a.m. to 5 p.m. EST, Monday through Friday. For Medical Information or to report an Adverse Event and/or Product Complaint, please contact Dr. Reddy’s Laboratories at 1-888-375-3784 between the hours of 9 a.m. to 7 p.m. EST, Monday through Friday. Patients should also contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, please call Dr. Reddy’s Medical Information at 1‑888‑375-3784, Monday through Friday, 9:00 a.m. to 7:00 p.m. (ET). You may also call the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.