Drug recall D-0529-2023
Product
Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC 47335-615-44); Rx only, Manufactured by: Gland Pharma Limited, Hyderabad-502307 India; Distributed by: Sun Phamaceutical Industries, Inc., Cranbury, NJ 08512.
Reason for recall
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Lots and codes
Lot Number: G1510001, Exp 11/2023; G151002, Exp. 12/2023; and G151003, Exp 02/2024
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 16,450 vials
- Distribution
- Nationwide in the USA
- Type
- N/A
- Recall initiated
- March 29, 2023
- Terminated
- October 31, 2023
Related products
- Norepinephrine Bitartrate – drug information
- NDC 47335-615 Norepinephrine Bitartrate · Norepinephrine Bitartrate 1 mg/mL · Sun Pharmaceutical Industries, Inc.