Why it was recalled
Lack of Assurance of Sterility
Product description
NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01.
Lot numbers, UPCs & expiration codes
S20415/BKY 12-Nov-21 S20418/BLB 13-Nov-21 S20452/BMI 5-Dec-21 S20463/BMT 9-Dec-21 S20464/BMU 18-Dec-21 S20478/BNF 23-Dec-21 S21021/BOI 6-Jan-22 S21033/BOU 20-Jan-22 S21047/BPH 21-Jan-22 S21059/BPU 28-Jan-22 S21094/BRE 18-Feb-22 S21117/BSB 3-Mar-22 S21118/BSC 10-Mar-22 S21138/BSW 17-Mar-22 S21227/BWA 7-May-22 S21239/BWK 12-May-22 S21279/BXW 5-Jun-22 S21295/BYL 16-Jun-22 S21298/BYO 18-Jun-22 S21339/BZZ 16-Jul-22 S21346/CAF 21-Jul-22 S21355/CAO 28-Jul-22 S21370/CBD 4-Aug-22 S21372/CBF 7-Aug-22 S21438/CDS 4-Sep-22
Where it was sold
U.S.A. Nationwide
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-0320-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 12, 2021
- FDA report date
- Jan 5, 2022
- Quantity
- 121,584 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SterRx, LLC
Original FDA data
Every field from FDA enforcement report D-0320-2022, exactly as published.
Show all FDA fields
- City
- Plattsburgh
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89059
- Address
- 141 Idaho Ave
- Code information
- S20415/BKY 12-Nov-21 S20418/BLB 13-Nov-21 S20452/BMI 5-Dec-21 S20463/BMT 9-Dec-21 S20464/BMU 18-Dec-21 S20478/BNF 23-Dec-21 S21021/BOI 6-Jan-22 S21033/BOU 20-Jan-22 S21047/BPH 21-Jan-22 S21059/BPU 28-Jan-22 S21094/BRE 18-Feb-22 S21117/BSB 3-Mar-22 S21118/BSC 10-Mar-22 S21138/BSW 17-Mar-22 S21227/BWA 7-May-22 S21239/BWK 12-May-22 S21279/BXW 5-Jun-22 S21295/BYL 16-Jun-22 S21298/BYO 18-Jun-22 S21339/BZZ 16-Jul-22 S21346/CAF 21-Jul-22 S21355/CAO 28-Jul-22 S21370/CBD 4-Aug-22 S21372/CBF 7-Aug-22 S21438/CDS 4-Sep-22
- Postal code
- 12903-3987
- Report date
- Jan 5, 2022
- Product type
- Drugs
- Recall number
- D-0320-2022
- Classification
- Class II
- Recalling firm
- SterRx, LLC
- Product quantity
- 121,584 bags
- Termination date
- Dec 6, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01.
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Nov 12, 2021
- Initial firm notification
- Press Release
- Center classification date
- Dec 29, 2021