D-1094-2020 Class I Terminated
FDA drug recall D-1094-2020 was initiated by Dr. Reddy's Laboratories, Inc. on March 16, 2020 and is designated Class I. Reason for recall: Defective Container: Recall is due to breaking and shattering of ampules upon opening The recall status is terminated (terminated December 22, 2022). Affected quantity: 10943 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- April 8, 2020
- Initiation Date
- March 16, 2020
- Termination Date
- December 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10943 cartons
Product Description
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
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: ACB902, ACB903, Exp. Date 03/2021; ACB904, Exp. Date 04/2021, ACB905, Exp. Date 06/2021