Infusion Options Recalls Diphenhydramine Infusion Due to Sterility Concerns
Infusion Options, Inc. is recalling Diphenhydramine 25 mg/50 mL NS infusions in New York due to a lack of assurance of sterility.
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 as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant health consequences (such as sterility failures in injectable drugs) map to a severity score of 4 (Severe), as they are not Class I but represent a serious risk.
Plain-English summary
Infusion Options, Inc. is recalling Diphenhydramine 25 mg/50 mL NS, a prescription-only medication, due to a lack of assurance of sterility. The recall covers all lots within their expiration dates and is limited to distribution in New York.
The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences. The specific hazard identified is the potential presence of non-sterile conditions in the product.
Healthcare providers and patients in New York who have received or possess this product should contact Infusion Options, Inc. for further instructions on how to return or dispose of the medication.
The recalled product
- Product
- DIPHENHYDRAMINE 25 MG/50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
- Manufacturer
- Infusion Options, Inc.
- Category
- Drug — Injectable
- Hazard
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)
- All lots within expiry
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 76 recalled by Infusion Options, Inc. 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.
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