FDA Drug recall D-0007-2023
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories…
- FDA Drug
- Class III
- completed
- Published 2022-10-12
On 2022-10-12 the FDA classified a Class III recall of Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories… by Dr Reddy S Laboratories, citing failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0007-2023 |
| Classification | Class III |
| Status | completed |
| Initiated | 2022-09-14 |
| Published | 2022-10-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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.
Identifiers
| ndc | 43598-405-11 |
|---|---|
| ndc | 43598-405-16 |
| code_info | Lot # ACB101, Exp 03/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0007-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.