FDA Recalls Tiagabine Hydrochloride Tablets Due to Impurity Specification Failures
Sun Pharmaceutical is recalling Tiagabine Hydrochloride Tablets (2 mg) due to out-of-specification impurities detected during testing. The recall affects lot HAC3339A distributed nationwide.
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 FDA Class II prescription drug recall involves detection of out-of-specification impurities, which represents a risk-of-harm product. No illnesses or injuries have been reported.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Tiagabine Hydrochloride Tablets, 2 mg, distributed nationwide in the United States. The recall affects approximately 8,880 bottles containing 30 tablets each from lot HAC3339A, which expires July 2023.
The recall was initiated because out-of-specification impurities were detected during Related Substances testing. The impurity levels exceeded the established quality standards for this medication.
Patients who have the affected lot should consult their healthcare provider or pharmacist for guidance regarding their medication supply. The affected lot number, HAC3339A, appears on the bottle label.
The recalled product
- Product
- TIAGABINE HYDROCHLORIDE (TIAGABINE HYDROCHLORIDE)
- Brand
- TIAGABINE HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
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 HAC3339A
- Expires 07/2023
UPCs (2)
- 0362756200838
- 0362756224834
Distribution
Distributed nationwide across the United States.
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