Diphenhydramine 18mg Injectable Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling Diphenhydramine 18mg syringes distributed nationwide due to lack of sterility assurance. The 15-bag recall affects injectable antihistamine products that may pose an infection risk if used.
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: The FDA classified this as a Class II recall due to lack of sterility assurance in an injectable medication. While no illnesses or injuries have been reported, injectable medications that lack sterility assurance represent a risk-of-harm product with potential for serious infection, meeting the criteria for High (3) severity.
Plain-English summary
Sentara Infusion Services is recalling Diphenhydramine 18mg in 3.6mL normal saline syringes distributed nationwide. A total of 15 bags of this prescription antihistamine medication have been recalled.
The recall has been issued due to lack of sterility assurance. Injectable medications must be manufactured and handled under strict sterile conditions to prevent microbial contamination.
Patients who received this medication should contact their healthcare provider to discuss alternative treatment options and any health concerns. Anyone in possession of affected syringes should not use them and should contact Sentara Infusion Services at 535 Independence Parkway, Suite 300, Chesapeake, VA 23320 for disposal instructions.
The recalled product
- Product
- Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Antihistamine
- Hazard
- lack-of-sterility
- contamination
- 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 (2)
- Beyond Use Date: December 29
- 2022
Distribution
Distributed nationwide across the United States.
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