Why it was recalled
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot Number: G1510001, Exp 11/2023; G151002, Exp. 12/2023; and G151003, Exp 02/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0529-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 29, 2023
- FDA report date
- Apr 19, 2023
- Quantity
- 16,450 vials
- Recall type
- N/A
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0529-2023, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91983
- Address
- 2 Independence Way
- Code information
- Lot Number: G1510001, Exp 11/2023; G151002, Exp. 12/2023; and G151003, Exp 02/2024
- Postal code
- 08540-6620
- Report date
- Apr 19, 2023
- Product type
- Drugs
- Recall number
- D-0529-2023
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 16,450 vials
- Termination date
- Oct 31, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 29, 2023
- Initial firm notification
- Center classification date
- Apr 10, 2023