Remicade Injection Recalled for Lack of Sterility Assurance
Walgreens Infusion Services is recalling Remicade (Infliximab) injection bags in Texas 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 and involves a lack of assurance of sterility, which is a significant safety hazard for an injectable medication.
Plain-English summary
Walgreens Infusion Services is recalling Remicade (Infliximab) injection, 5 mg/kg bags, in Texas. The recall was initiated because of a lack of assurance of sterility for the product. The affected product was compounded by Option Care 148 in San Antonio, Texas.
The recall includes all lots within the expiry date. The product is prescription-only and was distributed in Texas. The agency has classified this recall as Class II.
Consumers with this product should contact their healthcare provider or pharmacist for instructions on how to proceed.
The recalled product
- Product
- Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
- Manufacturer
- Walgreens Infusion Services
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1
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 33 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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