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
Reported: October 12, 2022 Initiated: September 14, 2022 #D-0007-2023
Product Description
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 for Recall
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 2,838 ampules
- Distribution
- USA nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 2,838 ampules.
Why was this product recalled? ▼
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 12, 2022. Severity: Low. Recall number: D-0007-2023.
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