Allopurinol Tablets Recalled for Green Plastic Contamination
Accord Healthcare is recalling Allopurinol 100 mg tablets due to the presence of a small piece of green plastic embedded in some tablets. The plastic poses a potential choking and ingestion hazard.
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 3/5 (High).
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: This is an FDA Class II recall of a risk-of-harm product (foreign object contamination). Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Accord Healthcare, Inc. is recalling Allopurinol Tablets USP, 100 mg, in 100-count bottles due to the presence of a small piece of green plastic embedded in the tablet. The recalled product was distributed nationwide in the United States.
The green plastic piece poses a potential choking and ingestion hazard to patients. The recall includes 87,576 bottles with lot numbers R2200455 and R2200456, with an expiration date of March 2025.
Patients who have obtained the recalled medication should contact their pharmacy or healthcare provider.
The recalled product
- Product
- ALLOPURINOL (ALLOPURINOL)
- Brand
- ALLOPURINOL
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Prescription Tablet
- Affected units
- 87,576
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)
- Lots: R2200455
- R2200456 Exp. 03/2025
Distribution
Distributed nationwide across the United States.
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