Class III
Terminated
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.
This recall has been terminated (originally issued April 19, 2023).
- Recall Initiated
- March 29, 2023
- Posted
- April 19, 2023
- Recall Number
- D-0529-2023
- Quantity
- 16,450 vials
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Distribution
Nationwide in the USA
Lot / Code Info
Lot Number: G1510001, Exp 11/2023; G151002, Exp. 12/2023; and G151003, Exp 02/2024
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