Food, drugs, devices › SUN PHARMACEUTICAL INDUSTRIES INC
Drug recall: Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packag
FDA enforcement event 91983 is a drug recall by SUN PHARMACEUTICAL INDUSTRIES INC of Princeton, NJ, initiated 29 Mar 2023 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 26% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 31 Oct 2023. Initiation: n/a. SUN PHARMACEUTICAL INDUSTRIES INC has 94 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ.
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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0529-2023 | 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.,… | 16,450 vials | Class III | Terminated | 19 Apr 2023 |
Context
Other enforcement events for SUN PHARMACEUTICAL INDUSTRIES INC
All 94 events for SUN PHARMACEUTICAL INDUSTRIES INC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Oct 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.