Why it was recalled
Lack of Assurance of Sterility
Product description
fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
Lot numbers, UPCs & expiration codes
Lot #: CHL, Exp. Date Dec 29, 2022
Where it was sold
Nationwide within the United States
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-1332-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 25, 2022
- FDA report date
- Aug 17, 2022
- Quantity
- 360 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SterRx, LLC
Original FDA data
Every field from FDA enforcement report D-1332-2022, exactly as published.
Show all FDA fields
- City
- Plattsburgh
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 90653
- Address
- 141 Idaho Ave
- Code information
- Lot #: CHL, Exp. Date Dec 29, 2022
- Postal code
- 12903-3987
- Report date
- Aug 17, 2022
- Product type
- Drugs
- Recall number
- D-1332-2022
- Classification
- Class II
- Recalling firm
- SterRx, LLC
- Product quantity
- 360 bags
- Termination date
- Jun 22, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 25, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 9, 2022