FDA Recalls Sucralfate Oral Suspension Due to Bacillus Cereus Contamination
VistaPharm is recalling 180 bottles of Sucralfate Oral Suspension nationwide due to Bacillus cereus contamination, a Class I recall. The affected lot (810300, expiring October 2023) should not be used.
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 I recall, which per the rubric requires a minimum severity of Severe (4). Bacillus cereus contamination in a non-sterile prescription drug product poses a reasonable risk of serious adverse health consequences, though no illnesses have been reported.
Plain-English summary
VistaPharm LLC is recalling Sucralfate Oral Suspension, 1g per 10mL, in 16 oz (414 mL) bottles. The recall affects 180 bottles distributed nationwide throughout the USA.
The product has been identified as contaminated with Bacillus cereus, a bacterium. This is a Class I recall, meaning there is a reasonable probability that the product will cause serious adverse health consequences.
The affected lot is 810300, with an expiration date of October 2023 (NDC 66689-305-16).
Patients taking this medication should contact their healthcare provider or pharmacist immediately. The product should not be used. Return it to the pharmacy for proper disposal.
The recalled product
- Product
- SUCRALFATE (SUCRALFATE)
- Brand
- SUCRALFATE
- Manufacturer
- VistaPharm LLC
- Hazard
- bacillus-cereus
- microbial-contamination
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)
- Lot#: 810300
- Exp 10/2023
UPCs (1)
- 0366689305165
Distribution
Distributed nationwide across the United States.
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