Walgreens Recalls Diphenhydramine Vials Due to Sterility Assurance Concerns
Walgreens Infusion Services is recalling Diphenhydramine 50 mg/ml vials due to a lack of sterility assurance. The products were distributed in six 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 agency classified this as an FDA Class II recall. According to the rubric, an FDA Class II recall involving a significant hazard like lack of sterility assurance in an injectable product corresponds to a Severe (4) rating.
Plain-English summary
Walgreens Infusion Services is recalling Diphenhydramine 50 mg/ml vials. The recall was initiated because of a lack of sterility assurance for the product.
The affected vials were distributed in Texas, Florida, Virginia, Georgia, Louisiana, and Mississippi. The source text indicates that all products within their expiry dates are included in this recall.
Consumers and healthcare providers should stop using the recalled vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Diphenhydramine 50 mg/ml vials
- Manufacturer
- Walgreens Infusion Services
- Category
- Drug — Injectable Medication
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 products within expiry.
Distribution
Part of a larger recall action
This product is one of 36 recalled by Walgreens Infusion Services 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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