Why it was recalled
Lack of Assurance of Sterility
Product description
Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.
Lot numbers, UPCs & expiration codes
Lots S21131/BSP, 10-Nov-21 S21132/BSQ, 11-Nov-21 S21139/BSX, 18-Nov-21 S21150/BTI, 24-Nov-21 S21158/BTP, 1-Dec-21 S21160/BTR, 2-Dec-21 & S21170/BUB, 9-Dec-21.
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-0300-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 12, 2021
- FDA report date
- Jan 5, 2022
- Quantity
- 15660 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SterRx, LLC
Original FDA data
Every field from FDA enforcement report D-0300-2022, 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
- Lots S21131/BSP, 10-Nov-21 S21132/BSQ, 11-Nov-21 S21139/BSX, 18-Nov-21 S21150/BTI, 24-Nov-21 S21158/BTP, 1-Dec-21 S21160/BTR, 2-Dec-21 & S21170/BUB, 9-Dec-21.
- Postal code
- 12903-3987
- Report date
- Jan 5, 2022
- Product type
- Drugs
- Recall number
- D-0300-2022
- Classification
- Class II
- Recalling firm
- SterRx, LLC
- Product quantity
- 15660 bags
- Termination date
- Dec 6, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Nov 12, 2021
- Initial firm notification
- Press Release
- Center classification date
- Dec 29, 2021