The Recall Desk
HighFDA (Drugs)·D-0930-2023·Announced 2023-07-26

Sodium Bicarbonate Injectable Solution Recalled for Sterility Assurance Issues

SterRx is recalling 137,304 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide because the manufacturer cannot assure the product meets sterility standards. Affected lots have expiration dates from July 2023 through February 2024.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves an injectable pharmaceutical with confirmed manufacturing control defects (lack of sterility assurance). Since no illnesses or injuries are reported in the source text, the score is High (3) per the rubric's criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

SterRx, LLC is recalling 137,304 bags of Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (NDC 70324-326-01). The product is supplied as 1,000 mL single-dose bags packaged in cases of six units.

The recall was initiated due to lack of assurance that the product meets FDA sterility standards. Lack of sterility in injectable medications poses a potential risk of microbial contamination.

The affected product was distributed nationwide in the United States. The recalled lots have expiration dates ranging from July 25, 2023 to February 8, 2024.

Healthcare facilities should immediately cease use of any product from the affected lots and contact their supplier for instructions regarding return or replacement. Any patients who may have received doses from recalled product should consult their healthcare provider.

The recalled product

Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
Manufacturer
SterRx, LLC
Category
Drug — Injectable Solution
Hazard
  • sterility-assurance
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #: 489344
  • Exp 25-Jul-23
  • 489352
  • Exp 26-Jul-23
  • 489361
  • Exp 27-Jul-23
  • 489387
  • 491647
  • Exp 28-Jul-23
  • 492181
  • Exp 29-Jul-23
  • 492199
  • 492201
  • Exp 2-Aug-23
  • 492210
  • 492228
  • Exp 3-Aug-23
  • 492236
  • 492244
  • Exp 4-Aug-23

Distribution

Distributed nationwide across the United States.

Related recalls

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