Celecoxib 200mg Capsules Recalled for Foreign Medication Contamination
Alembic Pharmaceuticals is recalling Celecoxib 200mg capsules from batch 2405014780 after discovering one Tadalafil 5mg tablet mixed inside a sealed bottle. The contaminated batch was distributed nationwide and in Puerto Rico.
What this means for you
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 involving the presence of a foreign medication within a prescription drug package. Although no illnesses or injuries have been reported, the hazard presents a significant risk of unintended medication exposure and potential adverse effects, meeting the criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Alembic Pharmaceuticals Limited is recalling specific lots of Celecoxib 200mg capsules (NDC 62332-142-71) due to foreign medication contamination. One Tadalafil 5mg tablet was discovered sealed inside a bottle of Celecoxib capsules during post-market monitoring.
The presence of a foreign medication poses a risk of medication error. If a patient takes this bottle without noticing the foreign tablet, they may inadvertently consume Tadalafil instead of Celecoxib, potentially causing unexpected side effects or harmful drug interactions.
The recall involves Celecoxib 200mg capsules, 500-count bottles, batch number 2405014780 with an expiration date of September 30, 2027. Approximately 2,946 affected bottles were distributed nationwide and in Puerto Rico.
Consumers who have bottles from this batch should stop using them and contact their pharmacy or healthcare provider for replacement. Healthcare providers and pharmacists should immediately check inventory for affected bottles and quarantine them from patient distribution.
The recalled product
- Product
- CELECOXIB (CELECOXIB)
- Brand
- CELECOXIB
- Manufacturer
- Alembic Pharmaceuticals Limited
- Category
- Drug
- Hazard
- contamination
- medication-mix-up
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 (3)
- Batch 2405014780
- Exp. Date: Sep. 30
- 2027
UPCs (4)
- 0362332142309
- 0362332143306
- 0362332141302
- 0362332140305
Distribution
Distributed nationwide across the United States.
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