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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 880
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.
Part of a larger recall action
This product is one of 26 recalled by SterRx, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 26 products in this recall →Related recalls
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