Tiagabine Hydrochloride Tablets recall: Impurity Out of Spec
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83
Why was Tiagabine Hydrochloride Tablets recalled?
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot HAC3339A, Expires 07/2023
- Product
- Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 8,880 30-count bottles
- Distribution
- Distributed nationwide in the USA.
- Recall date
- July 19, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)