D-0529-2023 Class III Terminated
FDA drug recall D-0529-2023 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on March 29, 2023 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring. The recall status is terminated (terminated October 31, 2023). Affected quantity: 16,450 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- April 19, 2023
- Initiation Date
- March 29, 2023
- Termination Date
- October 31, 2023
- Voluntary/Mandated
- N/A
- Product Quantity
- 16,450 vials
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot Number: G1510001, Exp 11/2023; G151002, Exp. 12/2023; and G151003, Exp 02/2024