SterRx Morphine Sulfate Injection Recalled for Sterility Assurance
SterRx is recalling 880 bags of Morphine Sulfate in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. Patients and healthcare providers should stop using affected units immediately.
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 of a sterile injectable drug with no reported illnesses stated in the source. Lack of sterility assurance in injectable products poses substantial risk of serious adverse health consequences including infection, which can be life-threatening, meeting the Severe criteria for Class II with significant risk of serious injury.
Plain-English summary
SterRx, LLC is recalling Morphine Sulfate in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL) with NDC 70324-427-01 and batch code S21292/BYI. The recall affects 880 bags distributed nationwide in the United States.
The product is being recalled due to lack of assurance of sterility. This is a prescription-only injectable medication, and compromised sterility poses a significant risk to patients who depend on this product for pain management.
Patients currently using this product should contact their healthcare provider immediately. Healthcare providers should cease dispensing the affected lots and notify their patients. The manufacturer is SterRx, LLC, located at 141 Idaho Ave., Plattsburgh, NY 12903. Healthcare providers with questions may contact the company or the FDA.
The recalled product
- Product
- MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Injectable / Morphine
- Hazard
- sterility-assurance
- contamination-risk
- 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)
- S21292/BYI
Distribution
Distributed nationwide across the United States.
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