The Recall Desk
SevereFDA (Drugs)·D-0301-2022·Announced 2022-01-05

SterRx Morphine Sulfate Injection Recalled for Sterility Assurance

SterRx is recalling Morphine Sulfate in 0.9% Sodium Chloride Injection (1 mg per mL) nationwide due to lack of assurance of sterility. The recall affects 880 units distributed across the United States.

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: The recall is classified by the FDA as Class II. Although no illnesses or hospitalizations are reported in the source text, a sterility assurance failure in an injectable drug—particularly an opioid administered directly into the body—carries inherent serious risk of infection and potential hospitalization. Class II status combined with the route of administration and risk profile justifies a Severe rating.

Plain-English summary

SterRx, LLC is recalling Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), NDC 70324-427-02, with lot/code S21317/BZE due to lack of assurance of sterility. A total of 880 units have been distributed nationwide in the United States.

This is a Class II recall issued by the Food and Drug Administration. Morphine Sulfate is a prescription injection used for pain management. If the product does not meet sterility standards, it may pose a risk of infection to patients who receive it.

Consumers and healthcare providers should not use this product. Patients who have received this injection should consult their healthcare provider. Healthcare facilities should quarantine and return the product to SterRx, LLC at 141 Idaho Avenue, Plattsburgh, NY 12903.

The recalled product

Product
Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02.
Manufacturer
SterRx, LLC
Category
Drug — Injectable / Opioid
Hazard
  • sterility-failure
  • infection-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 (1)

  • S21317/BZE

Distribution

Distributed nationwide across the United States.

Related recalls

Same category