The Recall Desk
SevereFDA (Drugs)·D-0313-2022·Announced 2022-01-05

Morphine Sulfate Injection Recalled for Lack of Sterility Assurance

SterRx is recalling 40 bags of Morphine Sulfate in 5% Dextrose Injection (1 mg per mL) distributed nationwide due to lack of assurance of sterility. The product is subject to contamination risk.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving a sterile injectable drug product. Lack of sterility assurance in injectable medications presents serious risk of infection and harm; the product is administered intravenously where contamination poses direct patient safety risk.

Plain-English summary

SterRx, LLC is recalling Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), NDC 70324-452-01, lot code S21293/BYJ, due to lack of assurance of sterility.

The recalled product was distributed nationwide in the United States. A total of 40 bags are affected by this recall.

Patients who have received this product should contact their healthcare provider immediately. Healthcare professionals and institutions that have received this product should cease use and contact SterRx for further instructions. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01.
Manufacturer
SterRx, LLC
Category
Drug — Injectable / Sterile Preparation
Hazard
  • sterility-failure
  • microbial-contamination

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 (1)

  • S21293/BYJ

Distribution

Distributed nationwide across the United States.

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