Recall: D-0529-2023

Class III - Minor Violations

Class IIIClassification

2023-03-29Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

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

Source: FDA drug enforcement report via openFDA (N/A). If you take this product, talk to your pharmacist or doctor before stopping it.