Drug 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.
D-0529-2023
Product summary
- Event
- Event 91983
- Status
- Terminated
- Classification
- Class III
- Quantity
- 16,450 vials
- Official record key
drug-enforcement:D-0529-2023
Official wording
Reason: Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Code information: Lot Number: G1510001, Exp 11/2023; G151002, Exp. 12/2023; and G151003, Exp 02/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications