Phytonadione Injectable Emulsion USP recall
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
Why was Phytonadione Injectable Emulsion USP recalled?
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # ACB101, Exp 03/2023
- 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
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Quantity
- 2,838 ampules
- Distribution
- USA nationwide
- Recall date
- October 12, 2022
- Classification
- Class III
- Status
- Completed
- Agency
- FDA (drug)