Norepinephrine Bitartrate Injection — Class III drug recall D-0529-2023
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2023-04-19, distributed nationwide. Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance nor
| Recall number | D-0529-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2023-03-29 |
| Classified | 2023-04-10 |
| Reported by FDA | 2023-04-19 |
| Terminated | 2023-10-31 |
| Distributed | Nationwide (US) |
| Quantity | 16,450 vials |
| Reason classes | specification failure |
| NDC | 47335-0615, 47335-0615-40, 47335-0615-44 |
| Lot numbers | G1510001, G151002, G151003 |
| Expiration dates | 2023-11, 2023-12, 2024-02 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0529-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.