Phytonadione Injectable Emulsion — Class I drug recall D-1094-2020
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2020-04-08, distributed nationwide. Defective Container: Recall is due to breaking and shattering of ampules upon opening
| Recall number | D-1094-2020 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2020-03-16 |
| Classified | 2020-04-06 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2022-12-22 |
| Distributed | Nationwide (US) |
| Quantity | 10,943 cartons |
| Reason classes | packaging |
| NDC | 43598-0405, 43598-0405-11, 43598-0405-16 |
| Lot numbers | ACB902, ACB903, ACB904, ACB905 |
| Expiration dates | 2021-03, 2021-04, 2021-06 |
Product
Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.
Reason for recall
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1094-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.