Recalls / Class III
Class IIID-0529-2023
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.
- Brand name
- Norepinephrine Bitartrate
- Generic name
- Norepinephrine Bitartrate
- Active ingredient
- Norepinephrine Bitartrate
- Route
- Intravenous
- NDC
- 47335-615
- FDA application
- ANDA211980
- Affected lot / code info
- Lot Number: G1510001, Exp 11/2023; G151002, Exp. 12/2023; and G151003, Exp 02/2024
Why it was recalled
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Type
- N/A
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 16,450 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-29
- FDA classified
- 2023-04-10
- Posted by FDA
- 2023-04-19
- Terminated
- 2023-10-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0529-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.