Recall: D-0007-2023

Class III - Minor Violations

Class IIIClassification

2022-09-14Initiated

CompletedStatus

Dr. Reddy's Laboratories, Inc.Firm

Product

Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16

Reason

Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

Distribution

USA nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.