D-0007-2023 Class III
FDA drug recall D-0007-2023 was initiated by Dr. Reddy's Laboratories, Inc. on Sep 14, 2022 and is designated Class III. Reason for recall: Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content. Affected quantity: 2,838 ampules.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 12, 2022
- Initiation Date
- Sep 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,838 ampules
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.
Distribution Pattern
USA nationwide
Code Information
Lot # ACB101, Exp 03/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0007-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026