Class III
Completed
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
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- September 14, 2022
- Posted
- October 12, 2022
- Recall Number
- D-0007-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,838 ampules
- Firm Location
- Princeton, NJ, United States
Reason for Recall
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Distribution
USA nationwide
Lot / Code Info
Lot # ACB101, Exp 03/2023
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