FDA Drug recall D-1094-2020
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 43…
- FDA Drug
- Class I
- terminated
- Published 2020-04-08
On 2020-04-08 the FDA classified a Class I recall of 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 43… by Dr Reddy S Laboratories, citing defective Container: Recall is due to breaking and shattering of ampules upon opening.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1094-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-03-16 |
| Published | 2020-04-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Identifiers
| ndc | 43598-405-11 |
|---|---|
| ndc | 43598-405-16 |
| code_info | Lot #: ACB902, ACB903, Exp. Date 03/2021; ACB904, Exp. Date 04/2021, ACB905, Exp. Date 06/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1094-2020%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.