Why it was recalled
Non-Sterility: firm's third party lab confirmed microbial contamination.
Product description
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01
Lot numbers, UPCs & expiration codes
Lot Number: BUP, exp. date 03/23/22
Where it was sold
Nationwide in the US
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-0767-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 10, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 1098 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SterRx, LLC
Original FDA data
Every field from FDA enforcement report D-0767-2021, exactly as published.
Show all FDA fields
- City
- Plattsburgh
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 88436
- Address
- 141 Idaho Ave
- Code information
- Lot Number: BUP, exp. date 03/23/22
- Postal code
- 12903-3987
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0767-2021
- Classification
- Class I
- Recalling firm
- SterRx, LLC
- Product quantity
- 1098 bags
- Termination date
- May 19, 2022
- Reason for recall
- Non-Sterility: firm's third party lab confirmed microbial contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Aug 10, 2021
- Initial firm notification
- Press Release
- Center classification date
- Aug 25, 2021